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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Hearing Aid / Earphone And Analysis Systems
510(k) Number K861113
Device Name ER-7C CLINICAL PROBE MICROPHONE
Applicant
ETYMOTIC RESEARCH
61 MARTIN LN.
ELK GROVE VILLAGE,  IL  60007
Applicant Contact EDWIN L DEVILBISE
Correspondent
ETYMOTIC RESEARCH
61 MARTIN LN.
ELK GROVE VILLAGE,  IL  60007
Correspondent Contact EDWIN L DEVILBISE
Regulation Number874.3310
Classification Product Code
ETW  
Date Received03/25/1986
Decision Date 04/23/1986
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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