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U.S. Department of Health and Human Services

Product Classification
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Device facial implant
Regulation Description Polytetrafluoroethylene with carbon fibers composite implant material.
Definition For use in plastic and reconstructive surgery. The devices can be used for cosmetic augmentation and corrections of soft tissue deformities in the face, including areas such as the nose, chin, and cheeks.
Physical State Solid implants
Technical Method Plastic surgery
Target Area face
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeODU
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 878.3500
Device Class 2
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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