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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 K905371
Device Name ITE HEARING AID
Applicant
AUDICARE HEARING CENTER
4620 U.S. 31 NORTH
TRAVERSE CITY,  MI  49686
Applicant Contact A BEVAN
Correspondent
AUDICARE HEARING CENTER
4620 U.S. 31 NORTH
TRAVERSE CITY,  MI  49686
Correspondent Contact A BEVAN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/29/1990
Decision Date 03/15/1991
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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