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FDA 510(k) Application Details - K991399
Device Classification Name
Probe, Radiofrequency Lesion
More FDA Info for this Device
510(K) Number
K991399
Device Name
Probe, Radiofrequency Lesion
Applicant
RADIONICS, INC.
22 TERRY AVE.
BURLINGTON, MA 01803-2516 US
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Contact
KEVIN J O'CONNELL
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
04/22/1999
Decision Date
09/21/1999
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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