FDA 510(k) Application Details - K993878

Device Classification Name Electromyograph, Diagnostic

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510(K) Number K993878
Device Name Electromyograph, Diagnostic
Applicant JACK'S ELECTRODES
2227 EAST CRESCENT DR.
ALTADENA, CA 91001 US
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Contact ANTHONY R.H. FENDER
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Regulation Number 890.1375

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Classification Product Code IKN
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Date Received 11/15/1999
Decision Date 02/01/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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