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U.S. Department of Health and Human Services

Product Classification
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Device diaphragm, contraceptive (and accessories)
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeHDW
Premarket Review GastroRenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 884.5350
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review
Accredited Persons
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