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U.S. Department of Health and Human Services

Product Classification
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Device mesh, surgical, collagen, fistula
Regulation Description Surgical mesh.
Definition For reinforcement of soft tissue where weakness exists during the repair of fistulas.
Physical State A collagen mesh; square, rectangular, round or of other various shapes
Technical Method A collagen mesh for the reinforcement of soft tissue
Target Area Anorectal, enterocutaneous, and recto-vaginal fistulas
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOXN
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
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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