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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Wound Dressing Without Thrombin Or Other Biologics
510(k) Number K893123
Device Name ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES
Applicant
Les Laboratorires Brothier, S.A.
Biometric Research Institute
1401 Wilson Blvd., Suite 400
Arlington,  VA  22209
Applicant Contact FRANK L HURLEY
Correspondent
Les Laboratorires Brothier, S.A.
Biometric Research Institute
1401 Wilson Blvd., Suite 400
Arlington,  VA  22209
Correspondent Contact FRANK L HURLEY
Classification Product Code
QSY  
Date Received04/25/1989
Decision Date 02/13/1990
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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