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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 K101510
Device Name FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR
Applicant
Endymed Medical, Ltd.
31 Haavoda St.
Binyamina,  IL 30500
Applicant Contact YORAM LEVY
Correspondent
Endymed Medical, Ltd.
31 Haavoda St.
Binyamina,  IL 30500
Correspondent Contact YORAM LEVY
Regulation Number878.4400
Classification Product Code
OUH  
Date Received06/01/2010
Decision Date 02/17/2011
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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