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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 K833486
Device Name IN-THE-EAR HEARING AID MODEL
Applicant
Danavox, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Danavox, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/07/1983
Decision Date 06/22/1984
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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