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U.S. Department of Health and Human Services

Product Classification
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Device mesh, surgical, non-absorbable, thoracic, chest wall reconstruction
Regulation Description Surgical mesh.
Definition For reinforcement of soft tissue where weakness exists during chest wall reconstruction.
Physical State A non-absorbable mesh; either square, rectangular, round or of various other shapes.
Technical Method A non-absorbable mesh that reinforces soft tissue
Target Area Chest wall
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOXA
Premarket Review Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
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
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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