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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name audiometer
510(k) Number K971080
Device Name MAICO MA52
Applicant
BERNAFON-MAICO, INC.
9675 WEST 76TH ST.
EDEN PRAIRIE,  MN  55344
Applicant Contact SCOTT SAVRE
Correspondent
BERNAFON-MAICO, INC.
9675 WEST 76TH ST.
EDEN PRAIRIE,  MN  55344
Correspondent Contact SCOTT SAVRE
Regulation Number874.1050
Classification Product Code
EWO  
Date Received03/25/1997
Decision Date 06/06/1997
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
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