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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, Drug
510(k) Number K882567
Device Name SKINCOTE
Applicant
Dynarex Corp.
One International Blvd.
Brewster,  NY  10509
Applicant Contact D SCHATTNER
Correspondent
Dynarex Corp.
One International Blvd.
Brewster,  NY  10509
Correspondent Contact D SCHATTNER
Classification Product Code
FRO  
Date Received06/22/1988
Decision Date 10/05/1988
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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