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FDA 510(k) Application Details - K120516
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K120516
Device Name
Electrode, Cutaneous
Applicant
OMRON HEALTHCARE, INC.
24301 WOODSAGE DRIVE
BONITA SPRINGS, FL 34134 US
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Contact
PAUL DRYDEN
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
02/21/2012
Decision Date
05/17/2012
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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