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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 K914314
Device Name FORTEX(TM) WOUND DRESSING
Applicant
Calgon Vestal Div.
P.O. Box 147
St. Louis,  MO  63166
Applicant Contact ANNE L SCHMITT
Correspondent
Calgon Vestal Div.
P.O. Box 147
St. Louis,  MO  63166
Correspondent Contact ANNE L SCHMITT
Regulation Number880.5090
Classification Product Code
KMF  
Date Received09/26/1991
Decision Date 10/23/1991
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
Predetermined Change
Control Plan Authorized		 No
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