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U.S. Department of Health and Human Services

Product Classification

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Device mesh, surgical, non-absorbable, large abdominal wall defects
Regulation Description Surgical mesh.
Definition For reinforcement of soft tissue where weakness exists in abdominal wall defects.
Physical State A non-absorbable mesh; either square, round, rectangular or of various other shapes
Technical Method A non-absorbable mesh that reinforces soft tissue
Target Area Abdominal wall
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOXJ
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
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible