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FDA 510(k) Application Details - K141586
Device Classification Name
Probe, Radiofrequency Lesion
More FDA Info for this Device
510(K) Number
K141586
Device Name
Probe, Radiofrequency Lesion
Applicant
DIROS TECHNOLOGY, INC.
120 GIBSON DRIVE
MARKHAM,ON L3R 2Z3 CA
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Contact
GEORGE DARMOS
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Regulation Number
882.4725
More FDA Info for this Regulation Number
Classification Product Code
GXI
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More FDA Info for this Product Code
Date Received
06/13/2014
Decision Date
12/30/2014
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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