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FDA 510(k) Application Details - K963208
Device Classification Name
Device, Nerve Conduction Velocity Measurement
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510(K) Number
K963208
Device Name
Device, Nerve Conduction Velocity Measurement
Applicant
NEUROTRON MEDICAL
2687 MAIN ST.
LAWRENCEVILLE, NJ 08628 US
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Contact
JACK GULDALIAN, JR.
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Regulation Number
882.1550
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Classification Product Code
JXE
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More FDA Info for this Product Code
Date Received
08/16/1996
Decision Date
07/14/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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