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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 Rd., Suite A
Redwood City,  CA  94063
Applicant Contact ADAM SAVAKUS
Correspondent
Relievant Medsystems
2688 Middlefield Rd., 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
Predetermined Change
Control Plan Authorized		 No
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