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U.S. Department of Health and Human Services

Product Classification
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Device mesh, surgical, deployer
Regulation Description Surgical mesh.
Definition Intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.G. Hernia repair).
Physical State manual laparoscopic surgical instrument ;operation handle and deployment section.
Technical Method intended to facilitate hernia mesh delivery and placement during laparoscopic ventral hernia repair.
Target Area abdominal cavity
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeORQ
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
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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