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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dressing, wound, drug
510(k) Number K112191
Device Name HEALEX BIOSPONGE WOUND DRESSING
Original Applicant
BIONOVA MEDICAL, INC
901 king st
suite 200
alexandria,  VA  22314
Original Contact deborah lavoie grayeski
Classification Product Code
FRO  
Date Received07/29/2011
Decision Date 06/05/2012
Decision substantially equivalent (SESE)
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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