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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K905526
Device Name AGARRELIEF 10 TRANSCUTANEOUS ELEC NERVE STIMULATOR
Applicant
Agar Ginosar Electronics
Kibbutz Ginosar
Ginosar,  IL 14980
Applicant Contact JONATHAN SHLAM
Correspondent
Agar Ginosar Electronics
Kibbutz Ginosar
Ginosar,  IL 14980
Correspondent Contact JONATHAN SHLAM
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received12/10/1990
Decision Date 06/21/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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