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FDA 510(k), K012025, MACROPORE SURGIWRAP (TS)
FDA 510(k), K012025, MACROPORE SURGIWRAP (TS)
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510(K) Number: K012025
Device Name: MACROPORE SURGIWRAP (TS)
Manufacturer: KENNETH K KLEINHENZ
Device Classification Name: Mesh, Surgical, Polymeric
Regulation Number: FTL
Classification Product Code: 06/28/2001
Date Received: 12/03/2001
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: MACROPORE SURGIWRAP (TS)
Manufacturer: KENNETH K KLEINHENZ
Device Classification Name: Mesh, Surgical, Polymeric
Regulation Number: FTL
Classification Product Code: 06/28/2001
Date Received: 12/03/2001
Decision Date: Substantially Equivalent (SESE)
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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