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FDA 510(k) K100821, PREVENA INCISION MANAGEMENT SYSTEM, by Kci USA, Inc.

FDA 510(k) K100821, PREVENA INCISION MANAGEMENT SYSTEM, by Kci USA, Inc.

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510(K) Number: K100821
Device Name: PREVENA INCISION MANAGEMENT SYSTEM
Manufacturer: Kci USA, Inc.
Device Classification Name: negative pressure wound therapy powered suction pump
Regulation Number: 878.4780
Classification Product Code: OMP
Date Received: 03/23/2010
Decision Date: 06/11/2010
Regulation Medical Specialty: General & Plastic Surgery
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