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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 K963039
Device Name SURESKIN STANDARD, BORDER, AND THIN
Applicant
Euromed A/S
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact DIANE E MINEAR
Correspondent
Euromed A/S
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact DIANE E MINEAR
Classification Product Code
FRO  
Date Received08/05/1996
Decision Date 09/23/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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