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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Depth
510(k) Number K051830
Device Name NEURODRIVE SYSTEM
Applicant
Alpha Omega , Ltd.
Ha'Avoda St., P.O. Box 810
Nazareth Illit,  IL 17105
Applicant Contact SHLOMO PUNDAK
Correspondent
Alpha Omega , Ltd.
Ha'Avoda St., P.O. Box 810
Nazareth Illit,  IL 17105
Correspondent Contact SHLOMO PUNDAK
Regulation Number882.1330
Classification Product Code
GZL  
Date Received07/06/2005
Decision Date 09/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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