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U.S. Department of Health and Human Services

Product Classification
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Device tissue adhesive internal use
Regulation Description Tissue adhesive.
Definition Intended for the fixation of surgical meshes.
Physical State tissue adhesive
Technical Method tissue adhesive used to fix mesh to tissue
Target Area internal use
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodePLJ
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type PMA
Regulation Number 878.4010
Device Class 3
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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