FDA 510(k) Application Details - K021537

Device Classification Name Electrode, Cutaneous

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510(K) Number K021537
Device Name Electrode, Cutaneous
Applicant VERMONT MEDICAL, INC.
INDUSTRIAL PARK
BELLOWS FALLS, VT 05101 US
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Contact MARC FILLION
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Regulation Number 882.1320

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Classification Product Code GXY
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Date Received 05/10/2002
Decision Date 03/03/2003
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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