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FDA 510(k) Application Details - K222281
Device Classification Name
Probe, Radiofrequency Lesion
More FDA Info for this Device
510(K) Number
K222281
Device Name
Probe, Radiofrequency Lesion
Applicant
Relievant Medsystems, Inc.
1230 Midas Way, Suite 200
Sunnyvale, CA 94085 US
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Contact
Thomas A. Slater
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
07/29/2022
Decision Date
10/26/2022
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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