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FDA 510(k) Application Details - K170708
Device Classification Name
Probe, Radiofrequency Lesion
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510(K) Number
K170708
Device Name
Probe, Radiofrequency Lesion
Applicant
Diros Technology Inc.
120 Gibson Drive
Markham L3R 2Z3 CA
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Contact
Ron Baker
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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
03/08/2017
Decision Date
06/27/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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