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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 K110750
Device Name PERIOPATCH
Applicant
Mis Implants Technologies , Ltd.
Bar Lev Industrial Park
P.O. Box 7
Bar Lev Industrial Park,  IL 20156
Applicant Contact IMAN KHORSHID
Correspondent
Mis Implants Technologies , Ltd.
Bar Lev Industrial Park
P.O. Box 7
Bar Lev Industrial Park,  IL 20156
Correspondent Contact IMAN KHORSHID
Classification Product Code
OLR  
Date Received03/17/2011
Decision Date 04/28/2011
Decision Substantially Equivalent (SESE)
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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