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U.S. Department of Health and Human Services

Product Classification

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Device mesh, surgical, absorbable, organ support
Regulation Description Surgical mesh.
Definition For reinforcement of soft tissue where weakness exists during organ support.
Physical State An absorbable mesh; either square, rectangular, round or of various other shapes
Technical Method An absorbable mesh that reinforces soft tissue
Target Area Various organs in need of temporary support
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOXL
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
Plastic and Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2)
Submission Type 510(k)
Regulation Number 878.3300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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