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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K890124
Device Name ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER
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 Number874.1050
Classification Product Code
EWO  
Date Received01/11/1989
Decision Date 07/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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