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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K903731
Device Name SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME
Applicant
TECA, INC.
THREE CAMPUS DR.
PLEASANTIVILLE,  NY  10570
Applicant Contact ARTHUR BLUMENFELD
Correspondent
TECA, INC.
THREE CAMPUS DR.
PLEASANTIVILLE,  NY  10570
Correspondent Contact ARTHUR BLUMENFELD
Regulation Number882.1870
Classification Product Code
GWF  
Date Received08/16/1990
Decision Date 02/04/1991
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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