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FDA 510(k) Application Details - K102566
Device Classification Name
Probe, Radiofrequency Lesion
More FDA Info for this Device
510(K) Number
K102566
Device Name
Probe, Radiofrequency Lesion
Applicant
DIROS TECHNOLOGY, INC.
232 HOOD ROAD
MARKHAM, ONTARIO L3R 3K8 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
09/07/2010
Decision Date
06/03/2011
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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