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U.S. Department of Health and Human Services

Product Classification
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Device prosthesis, ptfe/carbon-fiber
Regulation Description Polytetrafluoroethylene with carbon fibers composite implant material.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeKDA
Submission Type 510(k)
Regulation Number 878.3500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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