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FDA 510(k) Application Details - K092793
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K092793
Device Name
Electrode, Cutaneous
Applicant
BIO-MEDICAL RESEARCH, LTD.
PARKMORE BUSINESS PARK, WEST
GALWAY IE
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Contact
ANNE-MARIE KEENAN
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
09/11/2009
Decision Date
12/07/2009
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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