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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Nerve Conduction Velocity Measurement
510(k) Number K900378
Device Name EMG OPTION FOR MICROSHEV 4000
Applicant
Micro-Shev , Ltd.
P.O. Box 1026
Efrat,  IL 90962
Applicant Contact ALAN SCHWEBEL
Correspondent
Micro-Shev , Ltd.
P.O. Box 1026
Efrat,  IL 90962
Correspondent Contact ALAN SCHWEBEL
Regulation Number882.1550
Classification Product Code
JXE  
Date Received01/26/1990
Decision Date 04/10/1990
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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