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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 K943364
Device Name CORASSIST WOUND DRESSING
Applicant
Calgon Corp.
P.O. Box 147
St. Louis,  MO  63167
Applicant Contact ANNE SCHMITT
Correspondent
Calgon Corp.
P.O. Box 147
St. Louis,  MO  63167
Correspondent Contact ANNE SCHMITT
Regulation Number880.5090
Classification Product Code
KMF  
Date Received07/13/1994
Decision Date 08/03/1994
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
Predetermined Change
Control Plan Authorized		 No
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