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FDA 510(k) Application Details - K970694
Device Classification Name
Media, Electroconductive
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
882.1275
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Classification Product Code
GYB
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More FDA Info for this Product Code
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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