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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 K120098
Device Name STERILE DISPOSABLES FOR MER
Applicant
Alpha Omega Engineering , Ltd.
1 Ha'Rakefet St., P.O Box 4262
Zichron Yaacov,  IL 30900
Applicant Contact ILAN SHARON
Correspondent
Alpha Omega Engineering , Ltd.
1 Ha'Rakefet St., P.O Box 4262
Zichron Yaacov,  IL 30900
Correspondent Contact ILAN SHARON
Regulation Number882.1330
Classification Product Code
GZL  
Date Received01/12/2012
Decision Date 06/12/2012
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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