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U.S. Department of Health and Human Services

Product Classification
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Device prosthesis, testicle
Regulation Description Testicular prosthesis.
Definition Call for PMAs on 7/5/95 per 60 FR 17216 on 4/5/95
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeFTO
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type PMA
Regulation Number 876.3750
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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