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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 K963208
Device Name NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS)
Applicant
NEUROTRON MEDICAL
2687 MAIN ST.
LAWRENCEVILLE,  NJ  08628
Applicant Contact JACK GULDALIAN, JR.
Correspondent
NEUROTRON MEDICAL
2687 MAIN ST.
LAWRENCEVILLE,  NJ  08628
Correspondent Contact JACK GULDALIAN, JR.
Regulation Number882.1550
Classification Product Code
JXE  
Date Received08/16/1996
Decision Date 07/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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