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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 kit
510(k) Number K910011
Device Name POST SURGICAL KIT/POST BIOPSY KIT
Applicant
DERMATOLOGICAL RESEARCH LABORATORIES, INC.
577 AIRPORT BLVD., SUITE 130
BURLINGAME,  CA  94010
Applicant Contact KEVIN DAY
Correspondent
DERMATOLOGICAL RESEARCH LABORATORIES, INC.
577 AIRPORT BLVD., SUITE 130
BURLINGAME,  CA  94010
Correspondent Contact KEVIN DAY
Regulation Number880.5075
Classification Product Code
MCY  
Date Received01/02/1991
Decision Date 03/27/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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