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Title 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES
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 | 884.1 | Scope. |
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| 884.3 | Effective dates of requirement for premarket approval. |
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| 884.9 | Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
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| 884.1040 | Viscometer for cervical mucus. |
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| 884.1050 | Endocervical aspirator. |
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| 884.1060 | Endometrial aspirator. |
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| 884.1060 | Endometrial aspirator. |
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| 884.1100 | Endometrial brush. |
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| 884.1100 | Endometrial brush. |
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| 884.1175 | Endometrial suction curette and accessories. |
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| 884.1185 | Endometrial washer. |
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| 884.1185 | Endometrial washer. |
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| 884.1300 | Uterotubal carbon dioxide insufflator and accessories. |
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| 884.1425 | Perineometer. |
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| 884.1550 | Amniotic fluid sampler (amniocentesis tray). |
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| 884.1560 | Fetal blood sampler. |
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| 884.1600 | Transabdominal amnioscope (fetoscope) and accessories. |
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| 884.1630 | Colposcope. |
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| 884.1640 | Culdoscope and accessories. |
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| 884.1660 | Transcervical endoscope (amnioscope) and accessories. |
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| 884.1690 | Hysteroscope and accessories. |
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| 884.1700 | Hysteroscopic insufflator. |
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| 884.1720 | Gynecologic laparoscope and accessories. |
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| 884.1730 | Laparoscopic insufflator. |
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| 884.2050 | Obstetric data analyzer. |
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| 884.2225 | Obstetric-gynecologic ultrasonic imager. |
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| 884.2600 | Fetal cardiac monitor. |
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| 884.2620 | Fetal electroencephalographic monitor. |
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| 884.2640 | Fetal phonocardiographic monitor and accessories. |
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| 884.2660 | Fetal ultrasonic monitor and accessories. |
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| 884.2675 | Fetal scalp circular (spiral) electrode and applicator. |
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| 884.2685 | Fetal scalp clip electrode and applicator. |
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| 884.2700 | Intrauterine pressure monitor and accessories. |
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| 884.2720 | External uterine contraction monitor and accessories. |
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| 884.2740 | Perinatal monitoring system and accessories. |
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| 884.2900 | Fetal stethoscope. |
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| 884.2960 | Obstetric ultrasonic transducer and accessories. |
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| 884.2980 | Telethermographic system. |
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| 884.2982 | Liquid crystal thermographic system. |
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| 884.3200 | Cervical drain. |
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| 884.3575 | Vaginal pessary. |
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| 884.3650 | Fallopian tube prosthesis. |
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| 884.3900 | Vaginal stent. |
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| 884.4100 | Endoscopic electrocautery and accessories. |
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| 884.4100 | Endoscopic electrocautery and accessories. |
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| 884.4120 | Gynecologic electrocautery and accessories. |
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| 884.4150 | Bipolar endoscopic coagulator-cutter and accessories. |
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| 884.4150 | Bipolar endoscopic coagulator-cutter and accessories. |
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| 884.4160 | Unipolar endoscopic coagulator-cutter and accessories. |
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| 884.4250 | Expandable cervical dilator. |
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| 884.4260 | Hygroscopic Laminaria cervical dilator. |
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| 884.4270 | Vibratory cervical dilators. |
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| 884.4340 | Fetal vacuum extractor. |
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| 884.4400 | Obstetric forceps. |
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| 884.4500 | Obstetric fetal destructive instrument. |
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| 884.4520 | Obstetric-gynecologic general manual instrument. |
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| 884.4530 | Obstetric-gynecologic specialized manual instrument. |
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| 884.4550 | Gynecologic surgical laser. |
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| 884.4900 | Obstetric table and accessories. |
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| 884.5050 | Metreurynter-balloon abortion system. |
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| 884.5070 | Vacuum abortion system. |
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| 884.5100 | Obstetric anesthesia set. |
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| 884.5150 | Nonpowered breast pump. |
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| 884.5160 | Powered breast pump. |
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| 884.5225 | Abdominal decompression chamber. |
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| 884.5250 | Cervical cap. |
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| 884.5300 | Condom. |
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| 884.5310 | Condom with spermicidal lubricant. |
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| 884.5320 | Glans sheath. |
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| 884.5350 | Contraceptive diaphragm and accessories. |
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| 884.5360 | Contraceptive intrauterine device (IUD) and introducer. |
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| 884.5380 | Contraceptive tubal occlusion device (TOD) and introducer. |
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| 884.5390 | Perineal heater. |
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| 884.5400 | Menstrual cup. |
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| 884.5425 | Scented or scented deodorized menstrual pad. |
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| 884.5435 | Unscented menstrual pad. |
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| 884.5460 | Scented or scented deodorized menstrual tampon. |
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| 884.5470 | Unscented menstrual tampon. |
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| 884.5900 | Therapeutic vaginal douche apparatus. |
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| 884.5920 | Vaginal insufflator. |
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| 884.5940 | Powered vaginal muscle stimulator for therapeutic use. |
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| 884.5960 | Genital vibrator for therapeutic use. |
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| 884.6100 | Assisted reproduction needles. |
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| 884.6110 | Assisted reproduction catheters. |
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| 884.6120 | Assisted reproduction accessories. |
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| 884.6130 | Assisted reproduction microtools. |
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| 884.6140 | Assisted reproduction micropipette fabrication instruments. |
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| 884.6150 | Assisted reproduction micromanipulators and microinjectors. |
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| 884.6160 | Assisted reproduction labware. |
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| 884.6170 | Assisted reproduction water and water purification systems. |
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| 884.6180 | Reproductive media and supplements. |
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| 884.6190 | Assisted reproductive microscopes and microscope accessories. |
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