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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 K935298
Device Name INSTA-NERVE(TM) NERVE CONDUCTION MONITOR
Applicant
Insta Nerve Canada, Inc.
P.O. Box 16598
Fort Worth,  TX  76162
Applicant Contact RICHARD A HAMER
Correspondent
Insta Nerve Canada, Inc.
P.O. Box 16598
Fort Worth,  TX  76162
Correspondent Contact RICHARD A HAMER
Regulation Number882.1550
Classification Product Code
JXE  
Date Received11/02/1993
Decision Date 08/03/1994
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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