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U.S. Department of Health and Human Services

Product Classification

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Device micro-condom
Regulation Description Glans sheath.
Definition Call for pmas to be filed by 9/12/02 per 67 fr 40849 on 6/14/02.
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeLZL
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 884.5320
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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