FDA 510(k), K083898, SURGIMEND
FDA 510(k), K083898, SURGIMEND
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510(K) Number: K083898
Device Name: SURGIMEND
Manufacturer: TEI BIOSCIENCES INC.
Device Classification Name: mesh, surgical
Regulation Number: 878.3300
Classification Product Code: FTM
Date Received: 12/29/2008
Decision Date: 02/04/2009
Regulation Medical Specialty: General & Plastic Surgery
Device Name: SURGIMEND
Manufacturer: TEI BIOSCIENCES INC.
Device Classification Name: mesh, surgical
Regulation Number: 878.3300
Classification Product Code: FTM
Date Received: 12/29/2008
Decision Date: 02/04/2009
Regulation Medical Specialty: General & Plastic Surgery
- 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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