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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bandage, liquid
510(k) Number K912506
Device Name CRITIC-AID WOUND DRESSING
Applicant
SWEEN CORP.
1940 COMMERCE DR.
P.O. BOX 8300
N. MANKATO,  MN  56001
Applicant Contact ELLIOTT FARBER
Correspondent
SWEEN CORP.
1940 COMMERCE DR.
P.O. BOX 8300
N. MANKATO,  MN  56001
Correspondent Contact ELLIOTT FARBER
Regulation Number880.5090
Classification Product Code
KMF  
Date Received06/06/1991
Decision Date 03/02/1992
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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