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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 K870030
Device Name THE SCREENER GSI 55 ABR SCREENER
Applicant
Grason-Stadler, Inc.
537 Great Rd., P.O. Box 1400
Littleton,  MA  01460
Applicant Contact JANICE E PAINTER
Correspondent
Grason-Stadler, Inc.
537 Great Rd., P.O. Box 1400
Littleton,  MA  01460
Correspondent Contact JANICE E PAINTER
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received01/05/1987
Decision Date 03/13/1987
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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