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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 K921009
Device Name KALTOSTAT FORTEX WOUND DRESSING
Applicant
CALGON VESTAL DIV.
P.O. BOX 147
ST.LOUIS,  MO  63166 -0147
Applicant Contact MICHEAL EBERS
Correspondent
CALGON VESTAL DIV.
P.O. BOX 147
ST.LOUIS,  MO  63166 -0147
Correspondent Contact MICHEAL EBERS
Regulation Number880.5090
Classification Product Code
KMF  
Date Received03/03/1992
Decision Date 05/29/1992
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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