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U.S. Department of Health and Human Services

Product Classification
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Device mesh, surgical, collagen, plastics, facial implants
Regulation Description Surgical mesh.
Definition For reinforcement of soft tissue where weakness exists in facial plastic surgery.
Physical State A collagen mesh; either square, rectangular, round, or of other various shapes.
Technical Method A collagen mesh that reinforces soft tissue.
Target Area Face
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOWS
Premarket Review Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 878.3300
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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