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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Electroconductive
510(k) Number K161715
Device Name EndyGel
Applicant
Endymed Medical, Ltd.
12 Leshem St., N. Industrial Park
Caesarea,  IL 3088900
Applicant Contact Yoram Levy
Correspondent
Qsite
31 Haavoda St.
Binyamina,  IL 30500
Correspondent Contact Yoram Levy
Regulation Number882.1275
Classification Product Code
GYB  
Date Received06/21/2016
Decision Date 02/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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