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U.S. Department of Health and Human Services

Product Classification

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Device valve, tubal occlusion
Regulation Description Contraceptive tubal occlusion device (TOD) and introducer.
Definition Call for pmas 12/30/87 (52 fr 36883 10/1/87)).
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeHDO
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 884.5380
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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