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FDA 510(k) Application Details - K020670
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
882.1320
More FDA Info for this Regulation Number
Classification Product Code
GXY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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