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FDA 510(k) Application Details - K003896
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K003896
Device Name
Electrode, Cutaneous
Applicant
BEXLEY TRADING, INC.
1105 BUCKBRUSH DR.
FOLSOM, CA 95630 US
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Contact
MICHAEL ZMUDA
Other 510(k) Applications for this Contact
Regulation Number
882.1320
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Classification Product Code
GXY
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More FDA Info for this Product Code
Date Received
12/18/2000
Decision Date
04/24/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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