FDA 510(k) Application Details - K020670

Device Classification Name Electrode, Cutaneous

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510(K) Number K020670
Device Name Electrode, Cutaneous
Applicant PHYSIOMETRIX, INC.
FIVE BILLERICA PARK,
101 BILLERICA AVE.
NORTH BILLERICA, MA 01862 US
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Contact DAWN E FRAZER
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Regulation Number 882.1320

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Classification Product Code GXY
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Date Received 03/01/2002
Decision Date 10/08/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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