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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 K924185
Device Name DFS GENIUS BTE
Applicant
Gn Danavox, Inc.
5600 Rowland Rd. Suite 250
Minnetonka,  MN  55343
Applicant Contact DAVID J SMRIGA
Correspondent
Gn Danavox, Inc.
5600 Rowland Rd. Suite 250
Minnetonka,  MN  55343
Correspondent Contact DAVID J SMRIGA
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/20/1992
Decision Date 11/03/1992
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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