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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 K942270
Device Name SAF-GEL HYDRATING DERMAL WOUND DRESSING
Applicant
CALGON VESTAL DIV.
P.O. BOX 147
ST.LOUIS,  MO  63166 -0147
Applicant Contact MIKE EBERS
Correspondent
CALGON VESTAL DIV.
P.O. BOX 147
ST.LOUIS,  MO  63166 -0147
Correspondent Contact MIKE EBERS
Regulation Number880.5090
Classification Product Code
KMF  
Date Received05/10/1994
Decision Date 08/04/1994
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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