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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Hearing Aid / Earphone And Analysis Systems
510(k) Number K896996
Device Name CAS (COMPUTERIZED ANALYZER SYSTEM)
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 Number874.3310
Classification Product Code
ETW  
Date Received12/11/1989
Decision Date 08/09/1990
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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