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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 K842886
Device Name TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL
Applicant
TECA, INC.
THREE CAMPUS DR.
PLEASANTIVILLE,  NY  10570
Applicant Contact EDWARD SIROIS
Correspondent
TECA, INC.
THREE CAMPUS DR.
PLEASANTIVILLE,  NY  10570
Correspondent Contact EDWARD SIROIS
Regulation Number882.1460
Classification Product Code
GWN  
Date Received07/23/1984
Decision Date 12/12/1984
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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