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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 K891594
Device Name CERUMEN FILTER
Applicant
Gn Danavox, Inc.
6400 Flying Cloud Dr.
Eden Prairie,  MN  55344
Applicant Contact MARSHALL ROSNER
Correspondent
Gn Danavox, Inc.
6400 Flying Cloud Dr.
Eden Prairie,  MN  55344
Correspondent Contact MARSHALL ROSNER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/20/1989
Decision Date 05/10/1989
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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