FDA 510(k) Application Details - K974119

Device Classification Name Electrode, Needle

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510(K) Number K974119
Device Name Electrode, Needle
Applicant JACK'S ELECTRODES
2227 EAST CRESCENT DR.
ALTADENA, CA 91001 US
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Contact ANTHONY FENDER
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Regulation Number 882.1350

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Classification Product Code GXZ
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Date Received 10/31/1997
Decision Date 01/28/1998
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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