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FDA 510(k), K003323, COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
FDA 510(k), K003323, COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
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510(K) Number: K003323
Device Name: COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
Manufacturer: DAVOL, INC.
Device Classification Name: mesh, surgical, polymeric
Regulation Number: 878.3300
Classification Product Code: FTL
Date Received: 10/24/2000
Decision Date: 01/22/2001
Regulation Medical Specialty: General & Plastic Surgery
Device Name: COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
Manufacturer: DAVOL, INC.
Device Classification Name: mesh, surgical, polymeric
Regulation Number: 878.3300
Classification Product Code: FTL
Date Received: 10/24/2000
Decision Date: 01/22/2001
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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