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U.S. Department of Health and Human Services

Product Classification

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Device mesh, surgical, collagen, diaphragmatic hernia
Regulation Description Surgical mesh.
Definition For reinforcement of soft tissue where weakness exists during diaphragmatic hernia repair.
Physical State A collagen mesh; either square, round, rectangular or of various other shapes.
Technical Method A collagen mesh that reinforces soft tissue.
Target Area Diaphragm
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOWV
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