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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, cranial electrotherapy
510(k) Number K062284
Device Name CES ULTRA
Original Applicant
p.o. box 1031
snoqualmie,  WA  98065
Original Contact michael stevens
Regulation Number882.5800
Classification Product Code
Date Received08/07/2006
Decision Date 04/05/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls