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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K112191
Device Name HEALEX BIOSPONGE WOUND DRESSING
Applicant
Bionova Medical, Inc.
901 King St., Suite 200
Alexandria,  VA  22314
Applicant Contact DEBORAH LAVOIE GRAYESKI
Correspondent
Bionova Medical, Inc.
901 King St., Suite 200
Alexandria,  VA  22314
Correspondent Contact DEBORAH LAVOIE GRAYESKI
Classification Product Code
KGN  
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
Predetermined Change
Control Plan Authorized		 No
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