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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 K011114
Device Name ETYMOTIC RESEARCH ER-10D OAE PROBE
Applicant
ETYMOTIC RESEARCH
61 MARTIN LN.
ELK GROVE VILLAGE,  IL  60007
Applicant Contact ERIK GUNDERSEN
Correspondent
ETYMOTIC RESEARCH
61 MARTIN LN.
ELK GROVE VILLAGE,  IL  60007
Correspondent Contact ERIK GUNDERSEN
Regulation Number874.1050
Classification Product Code
EWO  
Date Received04/12/2001
Decision Date 07/03/2001
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
Predetermined Change
Control Plan Authorized		 No
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