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Section 884.1
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Effective dates of requirement for premarket approval |
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Section 884.3
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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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Section 884.9
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Viscometer for cervical mucus |
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Section 884.1040
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Endocervical aspirator |
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Section 884.1050
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Endometrial aspirator |
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Section 884.1060
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Endometrial brush |
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Section 884.1100
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Endometrial suction curette and accessories |
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Section 884.1175
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Endometrial washer |
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Section 884.1185
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Uterotubal carbon dioxide insufflator and accessories |
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Section 884.1300
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Perineometer |
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Section 884.1425
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Amniotic fluid sampler (amniocentesis tray) |
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Section 884.1550
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Fetal blood sampler |
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Section 884.1560
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Transabdominal amnioscope (fetoscope) and accessories |
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Section 884.1600
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Colposcope |
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Section 884.1630
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Culdoscope and accessories |
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Section 884.1640
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Transcervical endoscope (amnioscope) and accessories |
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Section 884.1660
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Hysteroscope and accessories |
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Section 884.1690
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Hysteroscopic insufflator |
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Section 884.1700
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Gynecologic laparoscope and accessories |
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Section 884.1720
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Laparoscopic insufflator |
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Section 884.1730
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Obstetric data analyzer |
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Section 884.2050
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Obstetric-gynecologic ultrasonic imager |
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Section 884.2225
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Fetal cardiac monitor |
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Section 884.2600
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Fetal electroencephalographic monitor |
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Section 884.2620
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Fetal phonocardiographic monitor and accessories |
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Section 884.2640
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Fetal ultrasonic monitor and accessories |
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Section 884.2660
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Fetal scalp circular (spiral) electrode and applicator |
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Section 884.2675
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Fetal scalp clip electrode and applicator |
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Section 884.2685
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Intrauterine pressure monitor and accessories |
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Section 884.2700
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External uterine contraction monitor and accessories |
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Section 884.2720
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Home uterine activity monitor |
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Section 884.2730
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Perinatal monitoring system and accessories |
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Section 884.2740
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Computerized Labor Monitoring System |
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Section 884.2800
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Fetal stethoscope |
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Section 884.2900
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Obstetric ultrasonic transducer and accessories |
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Section 884.2960
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Telethermographic system |
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Section 884.2980
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Liquid crystal thermographic system |
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Section 884.2982
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Breast lesion documentation system |
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Section 884.2990
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Cervical drain |
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Section 884.3200
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Vaginal pessary |
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Section 884.3575
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Fallopian tube prosthesis |
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Section 884.3650
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Vaginal stent |
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Section 884.3900
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Endoscopic electrocautery and accessories |
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Section 884.4100
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Gynecologic electrocautery and accessories |
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Section 884.4120
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Bipolar endoscopic coagulator-cutter and accessories |
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Section 884.4150
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Unipolar endoscopic coagulator-cutter and accessories |
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Section 884.4160
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Expandable cervical dilator |
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Section 884.4250
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Hygroscopic Laminaria cervical dilator |
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Section 884.4260
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Vibratory cervical dilators |
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Section 884.4270
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Fetal vacuum extractor |
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Section 884.4340
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Obstetric forceps |
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Section 884.4400
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Obstetric fetal destructive instrument |
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Section 884.4500
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Obstetric-gynecologic general manual instrument |
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Section 884.4520
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Obstetric-gynecologic specialized manual instrument |
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Section 884.4530
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Gynecologic surgical laser |
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Section 884.4550
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Obstetric table and accessories |
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Section 884.4900
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Metreurynter-balloon abortion system |
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Section 884.5050
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Vacuum abortion system |
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Section 884.5070
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Obstetric anesthesia set |
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Section 884.5100
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Nonpowered breast pump |
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Section 884.5150
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Powered breast pump |
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Section 884.5160
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Hemorrhoid prevention pressure wedge |
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Section 884.5200
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Abdominal decompression chamber |
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Section 884.5225
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Cervical cap |
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Section 884.5250
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Condom |
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Section 884.5300
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Condom with spermicidal lubricant |
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Section 884.5310
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Glans sheath |
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Section 884.5320
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Female condom |
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Section 884.5330
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Contraceptive diaphragm and accessories |
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Section 884.5350
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Contraceptive intrauterine device (IUD) and introducer |
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Section 884.5360
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Contraceptive tubal occlusion device (TOD) and introducer |
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Section 884.5380
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Perineal heater |
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Section 884.5390
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Menstrual cup |
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Section 884.5400
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Scented or scented deodorized menstrual pad |
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Section 884.5425
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Unscented menstrual pad |
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Section 884.5435
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Scented or scented deodorized menstrual tampon |
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Section 884.5460
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Unscented menstrual tampon |
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Section 884.5470
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Therapeutic vaginal douche apparatus |
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Section 884.5900
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Vaginal insufflator |
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Section 884.5920
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Powered vaginal muscle stimulator for therapeutic use |
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Section 884.5940
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Genital vibrator for therapeutic use |
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Section 884.5960
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Clitoral engorgement device |
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Section 884.5970
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Assisted reproduction needles |
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Section 884.6100
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Assisted reproduction catheters |
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Section 884.6110
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Assisted reproduction accessories |
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Section 884.6120
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Assisted reproduction microtools |
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Section 884.6130
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Assisted reproduction micropipette fabrication instruments |
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Section 884.6140
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Assisted reproduction micromanipulators and microinjectors |
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Section 884.6150
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Assisted reproduction labware |
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Section 884.6160
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Assisted reproduction water and water purification systems |
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Section 884.6170
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Reproductive media and supplements |
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Section 884.6180
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Assisted reproductive microscopes and microscope accessories |
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Section 884.6190
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Assisted Reproduction Embryo Image Assessment System |
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Section 884.6195
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Assisted reproduction laser system |
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Section 884.6200
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Scope |