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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 K943258
Device Name HYDROCOLLOID WOUND DRESSING
Applicant
Convatec, A Division of E.R. Squibb & Sons
200 Headquarters Park Dr.
Skillman,  NJ  08558
Applicant Contact KAREN HORGAN
Correspondent
Convatec, A Division of E.R. Squibb & Sons
200 Headquarters Park Dr.
Skillman,  NJ  08558
Correspondent Contact KAREN HORGAN
Regulation Number880.5090
Classification Product Code
KMF  
Date Received07/06/1994
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
Predetermined Change
Control Plan Authorized		 No
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