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FDA 510(k) Application Details - K150371
Device Classification Name
Probe, Radiofrequency Lesion
More FDA Info for this Device
510(K) Number
K150371
Device Name
Probe, Radiofrequency Lesion
Applicant
DIROS TECHNOLOGY, INC.
120 GIBSON DRIVE
MARKHAM L3R 2Z3 CA
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Contact
GEORGE DARMOS
Other 510(k) Applications for this Contact
Regulation Number
882.4725
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Classification Product Code
GXI
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More FDA Info for this Product Code
Date Received
02/13/2015
Decision Date
07/30/2015
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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