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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Lesion, Radiofrequency
510(k) Number K231675
Device Name OneRF Ablation System
Applicant
NeuroOne Medical Technologies Corp.
7599 Anagram Drive
Eden Prairie,  MN  55344
Applicant Contact Debra Kridner
Correspondent
Mcra, LLC
803 7th St., NW, 3rd Floor
Washington,  DC  20001
Correspondent Contact John Doucet
Regulation Number882.4400
Classification Product Code
GXD  
Subsequent Product Code
GXI  
Date Received06/08/2023
Decision Date 12/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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