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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oral Wound Dressing
510(k) Number K103054
Device Name PERIOPATCH
Applicant
Izun Pharmaceuticals Corporation
420 Lexington Ave.
New York,  NY  10170
Applicant Contact IRVING WIESEN
Correspondent
Izun Pharmaceuticals Corporation
420 Lexington Ave.
New York,  NY  10170
Correspondent Contact IRVING WIESEN
Classification Product Code
OLR  
Date Received10/15/2010
Decision Date 02/07/2011
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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