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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 K896531
Device Name NOVADERM
Applicant
Syncare Corp.
303 King St.
Charleston,  SC  29401
Applicant Contact TODD DERBIN
Correspondent
Syncare Corp.
303 King St.
Charleston,  SC  29401
Correspondent Contact TODD DERBIN
Regulation Number880.5090
Classification Product Code
KMF  
Date Received11/16/1989
Decision Date 04/13/1990
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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