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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 K922422
Device Name PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES
Applicant
AUDIOSCIENCE, INC.
5420 FELTL RD.
MINNETONKA,  MN  55343
Applicant Contact DON A ORTON
Correspondent
AUDIOSCIENCE, INC.
5420 FELTL RD.
MINNETONKA,  MN  55343
Correspondent Contact DON A ORTON
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/21/1992
Decision Date 06/10/1992
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
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