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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name conditioner, signal, physiological
510(k) Number K841110
Device Name NEUROTRAC
Applicant
INTERSPEC, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
INTERSPEC, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number882.1845
Classification Product Code
GWK  
Date Received02/14/1984
Decision Date 04/30/1984
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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