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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 K974152
Device Name OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)
Applicant
Bernafon-Maico, Inc.
9675 W. 76th St.
Eden Prairie,  MN  55344
Applicant Contact RAY ENROTH
Correspondent
Bernafon-Maico, Inc.
9675 W. 76th St.
Eden Prairie,  MN  55344
Correspondent Contact RAY ENROTH
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/04/1997
Decision Date 12/15/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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