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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 and burn, hydrogel w/drug and/or biologic
510(k) Number K070842
Device Name ULCELOOCIN ORAL ULCER PATCH
Applicant
SUNSHINE INTERNATIONAL GROUP, INC.
1333 BROADWAY
SUITE 1222
NEW YORK,  NY  10018
Applicant Contact LIPING HE
Correspondent
SUNSHINE INTERNATIONAL GROUP, INC.
1333 BROADWAY
SUITE 1222
NEW YORK,  NY  10018
Correspondent Contact LIPING HE
Classification Product Code
MGQ  
Date Received03/27/2007
Decision Date 06/07/2007
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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