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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 K961645
Device Name MRS-2D
Applicant
LEXICOR MEDICAL TECHNOLOGY, INC.
5589 ARAPAHOE AVE., #206
BOULDER,  CO  80303
Applicant Contact MICHAEL M SHUPE
Correspondent
LEXICOR MEDICAL TECHNOLOGY, INC.
5589 ARAPAHOE AVE., #206
BOULDER,  CO  80303
Correspondent Contact MICHAEL M SHUPE
Regulation Number882.5050
Classification Product Code
HCC  
Date Received04/29/1996
Decision Date 10/31/1996
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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