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U.S. Department of Health and Human Services

Product Classification

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Device mesh, surgical, absorbable, plastic and reconstructive surgery
Regulation Description Surgical mesh.
Definition For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.
Physical State An absorbable mesh; either square, round, rectangular or of various other shapes.
Technical Method An absorbable mesh that reinforces soft tissue
Target Area An area in need of plastic and reconstructive surgery
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOXF
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 878.3300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible