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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal
510(k) Number K935933
Device Name CUSTOM BURN DRESSING
Applicant
Mcneil Healthcare, Inc.
P.O. Box 964
Waterford,  CT  06385
Applicant Contact TIMOTHY D MCNEIL
Correspondent
Mcneil Healthcare, Inc.
P.O. Box 964
Waterford,  CT  06385
Correspondent Contact TIMOTHY D MCNEIL
Classification Product Code
EFQ  
Date Received12/13/1993
Decision Date 01/14/1994
Decision Substantially Equivalent (SESE)
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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