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FDA 510(k) Application Details - K062946
Device Classification Name
Probe, Radiofrequency Lesion
More FDA Info for this Device
510(K) Number
K062946
Device Name
Probe, Radiofrequency Lesion
Applicant
TOP CORP.
5536 TROWBRIDGE DRIVE
DUNWOODY, GA 30338 US
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Contact
CATHRYN N CAMBRIA
Other 510(k) Applications for this Contact
Regulation Number
882.4725
More FDA Info for this Regulation Number
Classification Product Code
GXI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/28/2006
Decision Date
02/15/2007
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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