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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nystagmograph
510(k) Number K964325
Device Name VISUALEYES: VIDEO EYE MONITOR
Applicant
Micromedical Technologies, Inc.
110 W. Walnut
Chatham,  IL  62629
Applicant Contact MANISH SUMANT
Correspondent
Micromedical Technologies, Inc.
110 W. Walnut
Chatham,  IL  62629
Correspondent Contact MANISH SUMANT
Regulation Number882.1460
Classification Product Code
GWN  
Date Received10/30/1996
Decision Date 07/15/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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