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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 K833451
Device Name TEL-STAR NUWAY & GENERIC E ASP-BP
Applicant
OMNI HEARING SYSTEMS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
OMNI HEARING SYSTEMS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/05/1983
Decision Date 11/14/1983
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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