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U.S. Department of Health and Human Services

Product Classification
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Device device, intrauterine, contraceptive and introducer
Regulation Description Contraceptive intrauterine device (IUD) and introducer.
Definition Called for PMAs in FR 5/5/86 PMAs to be filed by 8/4/86
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeHDT
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type PMA
Regulation Number 884.5360
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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