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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 Plastic and Reconstructive Surgery Devices (DHT4B)
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		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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