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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name over-the-counter radiofrequency coagulation device for wrinkle reduction
De Novo Number DEN150005
Device Name Newa Skin Therapy System
Requester
endymed medical, ltd.
12 leshem st., n. industrial park
caesarea,  IL 30889
Contact yoram levy
Regulation Number878.4420
Classification Product Code
PAY  
Date Received01/16/2015
Decision Date 12/18/2015
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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