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FDA 510(k), K003917, MODIFICATION TO FLUOROTEX II SURGICAL MESH
FDA 510(k), K003917, MODIFICATION TO FLUOROTEX II SURGICAL MESH
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510(K) Number: K003917
Device Name: MODIFICATION TO FLUOROTEX II SURGICAL MESH
Manufacturer: BRIDGER BIOMED, INC.
Device Classification Name: mesh, surgical, polymeric
Regulation Number: 878.3300
Classification Product Code: FTL
Date Received: 12/19/2000
Decision Date: 01/26/2001
Regulation Medical Specialty: General & Plastic Surgery
Device Name: MODIFICATION TO FLUOROTEX II SURGICAL MESH
Manufacturer: BRIDGER BIOMED, INC.
Device Classification Name: mesh, surgical, polymeric
Regulation Number: 878.3300
Classification Product Code: FTL
Date Received: 12/19/2000
Decision Date: 01/26/2001
Regulation Medical Specialty: General & Plastic Surgery
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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