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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cortical
510(k) Number K151354
Device Name Cervello STIM
Applicant
Blackrock Neuromed
630 Komas Dr., Suite 200
Salt Lake City,  UT  84108
Applicant Contact SHANNA RYAN
Correspondent
Spectramedex
117 W. S. St.
Oconomowoc,  WI  53066
Correspondent Contact JOHN ZIOBRO
Regulation Number882.1310
Classification Product Code
GYC  
Date Received05/20/2015
Decision Date 01/27/2016
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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