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FDA 510(k) K142646, XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and, by Genadyne Biotechnologies, Inc.

FDA 510(k) K142646, XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and, by Genadyne Biotechnologies, Inc.

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510(K) Number: K142646
Device Name: XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and
Manufacturer: Genadyne Biotechnologies, Inc.
Device Classification Name: negative pressure wound therapy powered suction pump
Regulation Number: 878.4780
Classification Product Code: OMP
Date Received: 09/17/2014
Decision Date: 04/30/2015
Regulation Medical Specialty: General & Plastic Surgery
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