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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 K081274
Device Name SURESKIN SILVER BANDAGES
Applicant
Euromed, Inc.
25 Corporate Dr.
Orangeburg,  NY  10962
Applicant Contact SUBHASH CHANDER
Correspondent
Euromed, Inc.
25 Corporate Dr.
Orangeburg,  NY  10962
Correspondent Contact SUBHASH CHANDER
Classification Product Code
FRO  
Date Received05/05/2008
Decision Date 05/28/2008
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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