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FDA 510(k) Application Details - K110118
Device Classification Name
Stimulator, Nerve, Battery-Powered
More FDA Info for this Device
510(K) Number
K110118
Device Name
Stimulator, Nerve, Battery-Powered
Applicant
XAVANT TECHNOLOGY (PTY), LTD.
169 GARSFONTEIN ROAD
ASHLEA GARDENS
PRETORIA, GAUTENG 0081 ZA
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Contact
BRIAN ROTHMAN
Other 510(k) Applications for this Contact
Regulation Number
868.2775
More FDA Info for this Regulation Number
Classification Product Code
BXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/18/2011
Decision Date
02/17/2011
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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