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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 K183177
Device Name Nitinol Thermocouple (TCN) Electrode
Applicant
Boston Scientific Corporation
25155 Rye Canyon Loop
Valencia,  CA  91355
Applicant Contact Adele Shoustal
Correspondent
Boston Scientific Corporation
25155 Rye Canyon Loop
Valencia,  CA  91355
Correspondent Contact Adele Shoustal
Regulation Number882.4725
Classification Product Code
GXI  
Date Received11/16/2018
Decision Date 03/08/2019
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
Recalls CDRH Recalls
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