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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 K092826
Device Name ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL
Applicant
American Biotech Labs
400 N. Washington St.
Suite 100
Alexandria,  VA  22314
Applicant Contact MIRIAM PROVOST
Correspondent
American Biotech Labs
400 N. Washington St.
Suite 100
Alexandria,  VA  22314
Correspondent Contact MIRIAM PROVOST
Classification Product Code
FRO  
Date Received09/14/2009
Decision Date 11/12/2009
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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