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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 K190259
Device Name Vesta RF Cannula
Applicant
Biomerics
6030 West Harold Gatty Drive
Salt Lake City,  UT  84116
Applicant Contact Jake Wakley
Correspondent
Biomerics
6030 West Harold Gatty Drive
Salt Lake City,  UT  84116
Correspondent Contact Jake Wakley
Regulation Number882.4725
Classification Product Code
GXI  
Date Received02/07/2019
Decision Date 02/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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