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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 Infection Control and Plastic Surgery Devices (DHT4B)
Infection Control and Plastic 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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