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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 K875360
Device Name THE BELTONE 2000 AUDIOMETER
Applicant
BELTONE ELECTRONICS CORP.
4201 WEST VICTORIA ST.
CHICAGO,  IL  60646
Applicant Contact GRETE NYGAARD
Correspondent
BELTONE ELECTRONICS CORP.
4201 WEST VICTORIA ST.
CHICAGO,  IL  60646
Correspondent Contact GRETE NYGAARD
Regulation Number874.1050
Classification Product Code
EWO  
Date Received12/31/1987
Decision Date 02/17/1988
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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