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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 K923226
Device Name EURION LOTOS PP HEARING AID
Applicant
EURION HEARING INSTRUMENTS
P.O. BOX 8816
GRAND RAPIDS,  MI  49518
Applicant Contact ROBERT A CUNNINGHAM
Correspondent
EURION HEARING INSTRUMENTS
P.O. BOX 8816
GRAND RAPIDS,  MI  49518
Correspondent Contact ROBERT A CUNNINGHAM
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/01/1992
Decision Date 07/30/1992
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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