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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hearing aid, air-conduction, prescription
510(k) Number K915450
Device Name IN THE EAR HEARING AID
Applicant
ZENITH/OMNI HEARING INSTRUMENTS, INC.
111 PARK ST., SUITE K
NEW HAVEN,  CT  06511
Applicant Contact RICHARD MCMAHON
Correspondent
ZENITH/OMNI HEARING INSTRUMENTS, INC.
111 PARK ST., SUITE K
NEW HAVEN,  CT  06511
Correspondent Contact RICHARD MCMAHON
Regulation Number874.3300
Classification Product Code
ESD  
Date Received12/05/1991
Decision Date 02/27/1992
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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