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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 K844681
Device Name EMG REPORT GENERATOR
Applicant
MICROSYSTEM CONTROLS
790 VEDADO WAY NE
ATLANTA,  GA  30308
Applicant Contact GORDON L GIBBY
Correspondent
MICROSYSTEM CONTROLS
790 VEDADO WAY NE
ATLANTA,  GA  30308
Correspondent Contact GORDON L GIBBY
Regulation Number882.1550
Classification Product Code
JXE  
Date Received11/30/1984
Decision Date 02/26/1985
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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