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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Auditory, Evoked Response
510(k) Number K863156
Device Name TECA/MEDELEC AUDIOSTAR
Applicant
Teca, Inc.
Three Campus Dr.
Pleasantiville,  NY  10570
Applicant Contact EDWARD R SIROIS
Correspondent
Teca, Inc.
Three Campus Dr.
Pleasantiville,  NY  10570
Correspondent Contact EDWARD R SIROIS
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received08/18/1986
Decision Date 02/03/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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