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FDA 510(k), K994328, SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX
FDA 510(k), K994328, SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX
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510(K) Number: K994328
Device Name: SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX
Manufacturer: GENZYME CORP.
Device Classification Name: mesh, surgical, polymeric
Regulation Number: 878.3300
Classification Product Code: FTL
Date Received: 12/22/1999
Decision Date: 03/02/2000
Regulation Medical Specialty: General & Plastic Surgery
Device Name: SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX
Manufacturer: GENZYME CORP.
Device Classification Name: mesh, surgical, polymeric
Regulation Number: 878.3300
Classification Product Code: FTL
Date Received: 12/22/1999
Decision Date: 03/02/2000
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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