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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 Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type PMA
Regulation Number 884.5320
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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