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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 K953037
Device Name CUSTOM CANAL & FULL CONCHA INSTR (CLASS D CIR OPT)
Applicant
MIDWEST CITY HEARING AID CENTER
1401 SOUTH MIDWEST BLVD.
MIDWEST CITY,  OK  73110
Applicant Contact FRANK CARTER
Correspondent
MIDWEST CITY HEARING AID CENTER
1401 SOUTH MIDWEST BLVD.
MIDWEST CITY,  OK  73110
Correspondent Contact FRANK CARTER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/19/1995
Decision Date 07/20/1995
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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