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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 K915346
Device Name CUSTOM CANAL HEARING AID
Applicant
Dicta Laboratories
P.O. Box 16398
St. Paul,  MN  55116
Correspondent
Dicta Laboratories
P.O. Box 16398
St. Paul,  MN  55116
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/26/1991
Decision Date 01/15/1992
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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