21 C.F.R. PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart A--GENERAL PROVISIONS
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| Effective dates of requirement for premarket approval.
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| Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
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Subpart B--OBSTETRICAL AND GYNECOLOGICAL DIAGNOSTIC DEVICES
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| Viscometer for cervical mucus.
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| Endometrial suction curette and accessories.
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| Uterotubal carbon dioxide insufflator and accessories.
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| Amniotic fluid sampler (amniocentesis tray).
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| Transabdominal amnioscope (fetoscope) and accessories.
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| Culdoscope and accessories.
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| Transcervical endoscope (amnioscope) and accessories.
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| Hysteroscope and accessories.
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| Hysteroscopic insufflator.
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| Gynecologic laparoscope and accessories.
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| Laparoscopic insufflator.
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Subpart C--OBSTETRICAL AND GYNECOLOGICAL MONITORING DEVICES
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| Obstetric-gynecologic ultrasonic imager.
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| Fetal electroencephalographic monitor.
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| Fetal phonocardiographic monitor and accessories.
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| Fetal ultrasonic monitor and accessories.
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| Fetal scalp circular (spiral) electrode and applicator.
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| Fetal scalp clip electrode and applicator.
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| Intrauterine pressure monitor and accessories.
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| External uterine contraction monitor and accessories.
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| Home uterine activity monitor.
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| Perinatal monitoring system and accessories.
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| Obstetric ultrasonic transducer and accessories.
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| Telethermographic system.
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| Liquid crystal thermographic system.
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| Breast lesion documentation system.
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Subpart D--OBSTETRICAL AND GYNECOLOGICAL PROSTHETIC DEVICES
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| Fallopian tube prosthesis.
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Subpart E--OBSTETRICAL AND GYNECOLOGICAL SURGICAL DEVICES
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| Endoscopic electrocautery and accessories.
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| Gynecologic electrocautery and accessories.
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| Bipolar endoscopic coagulator-cutter and accessories.
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| Unipolar endoscopic coagulator-cutter and accessories.
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| Expandable cervical dilator.
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| Hygroscopic Laminaria cervical dilator.
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| Vibratory cervical dilators.
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| Obstetric fetal destructive instrument.
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| Obstetric-gynecologic general manual instrument.
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| Obstetric-gynecologic specialized manual instrument.
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| Gynecologic surgical laser.
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| Obstetric table and accessories.
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Subpart F--OBSTETRICAL AND GYNECOLOGICAL THERAPEUTIC DEVICES
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| Metreurynter-balloon abortion system.
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| Obstetric anesthesia set.
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| Abdominal decompression chamber.
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| Condom with spermicidal lubricant.
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| Contraceptive diaphragm and accessories.
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| Contraceptive intrauterine device (IUD) and introducer.
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| Contraceptive tubal occlusion device (TOD) and introducer.
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| Scented or scented deodorized menstrual pad.
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| Scented or scented deodorized menstrual tampon.
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| Unscented menstrual tampon.
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| Therapeutic vaginal douche apparatus.
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| Powered vaginal muscle stimulator for therapeutic use.
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| Genital vibrator for therapeutic use.
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| Clitoral engorgement device.
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Subpart G--ASSISTED REPRODUCTION DEVICES
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| Assisted reproduction needles.
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| Assisted reproduction catheters.
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| Assisted reproduction accessories.
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| Assisted reproduction microtools.
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| Assisted reproduction micropipette fabrication instruments.
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| Assisted reproduction micromanipulators and microinjectors.
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| Assisted reproduction labware.
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| Assisted reproduction water and water purification systems.
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| Reproductive media and supplements.
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| Assisted reproductive microscopes and microscope accessories.
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| Assisted reproduction laser system.
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