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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound And Burn, Occlusive
510(k) Number K940895
Device Name EPIVIEW
Applicant
Convatec, A Bristol-Myers Squibb Co.
200 Headquarters Park Dr.
Skillman,  NJ  08558
Applicant Contact KAREN HORGAN
Correspondent
Convatec, A Bristol-Myers Squibb Co.
200 Headquarters Park Dr.
Skillman,  NJ  08558
Correspondent Contact KAREN HORGAN
Classification Product Code
MGP  
Date Received02/24/1994
Decision Date 11/22/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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