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FDA 510(k), K053066, SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH
FDA 510(k), K053066, SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH
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510(K) Number: K053066
Device Name: SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH
Manufacturer: GENZYME CORPORATION
Device Classification Name: mesh, surgical, polymeric
Regulation Number: 878.3300
Classification Product Code: FTL
Date Received: 11/01/2005
Decision Date: 12/19/2005
Regulation Medical Specialty: General & Plastic Surgery
Device Name: SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH
Manufacturer: GENZYME CORPORATION
Device Classification Name: mesh, surgical, polymeric
Regulation Number: 878.3300
Classification Product Code: FTL
Date Received: 11/01/2005
Decision Date: 12/19/2005
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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