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U.S. Department of Health and Human Services

Product Classification
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Device mesh, surgical, non-absorbable, facial implants for plastic surgery
Regulation Description Surgical mesh.
Definition For reinforcement of soft tissue where weakness exists in facial plastic surgery.
Physical State A plastic polymer mesh; either square, rectangular, or round.
Technical Method A non-absorbable mesh that reinforces soft tissue.
Target Area Face
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOWR
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
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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