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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
Predetermined Change
Control Plan Authorized		 No
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