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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 Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
Submission Type PMA
Regulation Number 884.5360
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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