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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Skin Resurfacing Rf Applicator
510(k) Number K130501
Device Name INTENSIF
Applicant
Endymed Medical, Ltd.
Haavoda 31 St.
Binyamina,  IL 30500
Applicant Contact YORAM LEVY
Correspondent
Endymed Medical, Ltd.
Haavoda 31 St.
Binyamina,  IL 30500
Correspondent Contact YORAM LEVY
Regulation Number878.4400
Classification Product Code
OUH  
Subsequent Product Code
GEI  
Date Received02/27/2013
Decision Date 03/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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