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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 K953728
Device Name RX12 LINEAR FULL SHELL AND IN THE CANAL
Applicant
MIDWEST CITY HEARING AID CENTER
1401 SOUTH MIDWEST BLVD.
MIDWEST CITY,  OK  73110
Applicant Contact FRANKLIN D CARTER
Correspondent
MIDWEST CITY HEARING AID CENTER
1401 SOUTH MIDWEST BLVD.
MIDWEST CITY,  OK  73110
Correspondent Contact FRANKLIN D CARTER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/10/1995
Decision Date 09/12/1995
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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