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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 K180369
Device Name Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
Applicant
Relievant Medsystems
385 Moffett Park Drive, Suite 105
Sunnyvale,  CA  94089
Applicant Contact Alex DiNello
Correspondent
Relievant Medsystems
385 Moffett Park Drive, Suite 105
Sunnyvale,  CA  94089
Correspondent Contact Alex DiNello
Regulation Number882.4725
Classification Product Code
GXI  
Date Received02/12/2018
Decision Date 09/14/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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