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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 K970430
Device Name ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCI
Applicant
Midwest City Hearing Aid Center
1401 S. Midwest Blvd.
Midwest City,  OK  73110
Applicant Contact FRANKLIN D CARTER
Correspondent
Midwest City Hearing Aid Center
1401 S. Midwest Blvd.
Midwest City,  OK  73110
Correspondent Contact FRANKLIN D CARTER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received02/04/1997
Decision Date 03/11/1997
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
Predetermined Change
Control Plan Authorized		 No
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