FDA 510(k) Application Details - K970694

Device Classification Name Media, Electroconductive

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510(K) Number K970694
Device Name Media, Electroconductive
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 882.1275

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Classification Product Code GYB
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Date Received 02/25/1997
Decision Date 05/14/1997
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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