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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 K980377
Device Name FONIX FP35 HEARING AID ANALYZER
Applicant
FRYE ELECTRONICS, INC.
9826 S.W. TIGARD ST.
TIGARD,  OR  97223
Applicant Contact GEORGE J FRYE
Correspondent
FRYE ELECTRONICS, INC.
9826 S.W. TIGARD ST.
TIGARD,  OR  97223
Correspondent Contact GEORGE J FRYE
Regulation Number874.3310
Classification Product Code
ETW  
Subsequent Product Code
EWO  
Date Received02/02/1998
Decision Date 03/18/1998
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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