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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 K912399
Device Name HEARING AID (ALL-IN-THE-EAR)
Applicant
Carlson'S Heritage Hearing Aid Center
3004 N. St.
Anderson,  CA  96007
Applicant Contact NORMAN R CARLSON
Correspondent
Carlson'S Heritage Hearing Aid Center
3004 N. St.
Anderson,  CA  96007
Correspondent Contact NORMAN R CARLSON
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/30/1991
Decision Date 03/12/1992
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
Predetermined Change
Control Plan Authorized		 No
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