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U.S. Department of Health and Human Services

Product Classification

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Device mesh, surgical, absorbable, abdominal hernia
Regulation Description Surgical mesh.
Definition For reinforcement of soft tissue where weakness exists during hernia repair.
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 Including but not limited to abdominal, inguinal, femoral, umbilical, and incisional hernias.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOWT
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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