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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 K920038
Device Name NEUROSEARCH-4
Applicant
LEXICOR
2585 CENTRAL AVE.
BOULDER,  CO  80301
Applicant Contact KENNETH NICHOLS
Correspondent
LEXICOR
2585 CENTRAL AVE.
BOULDER,  CO  80301
Correspondent Contact KENNETH NICHOLS
Regulation Number882.5050
Classification Product Code
HCC  
Subsequent Product Codes
GWQ   GWS  
Date Received01/06/1992
Decision Date 02/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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