FDA 510(k) Application Details - K990015

Device Classification Name Electrode, Needle, Diagnostic Electromyograph

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510(K) Number K990015
Device Name Electrode, Needle, Diagnostic Electromyograph
Applicant TECHNOMED EUROPE
STATIONSTRAAT 122
P.O. BOX 239
6191 BG BEEK 6191 BG NL
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Contact HARRY KNUTH
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Regulation Number 890.1385

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Classification Product Code IKT
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Date Received 01/04/1999
Decision Date 05/27/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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