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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 K022510
Device Name FONIX, MODEL 7000
Applicant
FRYE ELECTRONICS, INC.
9826 S.W. TIGARD ST.
TIGARD,  OR  97223
Applicant Contact KRISTINA FRYE
Correspondent
FRYE ELECTRONICS, INC.
9826 S.W. TIGARD ST.
TIGARD,  OR  97223
Correspondent Contact KRISTINA FRYE
Regulation Number874.3310
Classification Product Code
ETW  
Date Received07/30/2002
Decision Date 08/27/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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