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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 K930553
Device Name CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT
Applicant
ETYMOTIC RESEARCH
61 MARTIN LN.
ELK GROVE VILLAGE,  IL  60007
Applicant Contact MEAD C KILLION
Correspondent
ETYMOTIC RESEARCH
61 MARTIN LN.
ELK GROVE VILLAGE,  IL  60007
Correspondent Contact MEAD C KILLION
Regulation Number874.1050
Classification Product Code
EWO  
Date Received02/03/1993
Decision Date 09/29/1993
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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