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FDA 510(k) Application Details - K163236
Device Classification Name
Probe, Radiofrequency Lesion
More FDA Info for this Device
510(K) Number
K163236
Device Name
Probe, Radiofrequency Lesion
Applicant
Halyard Health, Inc.
5405 Windward Parkway
Alpharetta, GA 30004 US
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Contact
Mary Ann B Kinard
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
11/17/2016
Decision Date
12/16/2016
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
Y
Expedited Review
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