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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 K082333
Device Name ASAP WOUND DRESSING GEL
Applicant
American Biotech Labs
1400 16th St., NW
Suite 101
Washington,  DC  20036
Applicant Contact JAMES S TURNER
Correspondent
American Biotech Labs
1400 16th St., NW
Suite 101
Washington,  DC  20036
Correspondent Contact JAMES S TURNER
Classification Product Code
FRO  
Date Received08/14/2008
Decision Date 04/02/2009
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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