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FDA 510(k) Application Details - K051635
Device Classification Name
Stimulator, Nerve, Peripheral, Electric
More FDA Info for this Device
510(K) Number
K051635
Device Name
Stimulator, Nerve, Peripheral, Electric
Applicant
GE HEALTHCARE
86 PILGRIM ROAD
NEEDHAM, MA 02492 US
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Contact
JOEL C KENT
Other 510(k) Applications for this Contact
Regulation Number
868.2775
More FDA Info for this Regulation Number
Classification Product Code
KOI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/20/2005
Decision Date
07/15/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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