FDA 510(k) Application Details - K020735

Device Classification Name Electrode, Cutaneous

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510(K) Number K020735
Device Name Electrode, Cutaneous
Applicant CATHAY INTERNATIONAL, LTD.
RM. 8F-3, NO. 29, CHUNGSHAN N.
RD. SEC 3
TAIPEI TW
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Contact ANNE JEN
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Regulation Number 882.1320

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Classification Product Code GXY
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Date Received 03/06/2002
Decision Date 07/12/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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