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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: KXA
Date Received: 06/28/2001
Decision Date: 12/03/2001
Decision: 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: KXA
Date Received: 06/28/2001
Decision Date: 12/03/2001
Decision: Substantially Equivalent (SESE)
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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