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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name probe, radiofrequency lesion
510(k) Number K153272
Device Name INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set
Applicant
RELIEVANT MEDSYSTEMS
2688 MIDDLEFIELD ROAD, SUITE A
REDWOOD CITY,  CA  94063
Applicant Contact ADAM SAVAKUS
Correspondent
RELIEVANT MEDSYSTEMS
2688 MIDDLEFIELD ROAD, SUITE A
REDWOOD CITY,  CA  94063
Correspondent Contact ADAM SAVAKUS
Regulation Number882.4725
Classification Product Code
GXI  
Date Received11/12/2015
Decision Date 07/09/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT00027352
Reviewed by Third Party No
Combination Product No
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