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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K071866
Device Name NTRAINER SYSTEM
Applicant
KCBIOMEDIX, INC.
4200 SW SAPELO DR.
LEES SUMMIT,  MO  64082
Applicant Contact JAMES E STANLEY
Correspondent
KCBIOMEDIX, INC.
4200 SW SAPELO DR.
LEES SUMMIT,  MO  64082
Correspondent Contact JAMES E STANLEY
Regulation Number882.5050
Classification Product Code
HCC  
Date Received07/06/2007
Decision Date 02/01/2008
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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