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U.S. Department of Health and Human Services

Product Classification
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Device prosthesis, penis, rigid rod
Regulation Description Penile rigidity implant.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeFTQ
Submission Type 510(k)
Regulation Number 876.3630
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for the Content of Premarket Notifications for Penile Rigidity Implants; Final
Third Party Review Not Third Party Eligible
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