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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
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