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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 K905679
Device Name 133 SERIES BTE
Applicant
GN DANAVOX, INC.
5600 ROWLAND RD., SUITE 250
MINNETONKA,  MN  55343
Applicant Contact WAYNE MORRIS
Correspondent
GN DANAVOX, INC.
5600 ROWLAND RD., SUITE 250
MINNETONKA,  MN  55343
Correspondent Contact WAYNE MORRIS
Regulation Number874.3300
Classification Product Code
ESD  
Date Received12/19/1990
Decision Date 01/28/1991
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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