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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 K913221
Device Name TYPE FA10 AUDIOMETER
Applicant
Frye Electronics, Inc.
P.O. Box 23391
9826 SW Tigard St.
Tigard,  OR  97223
Applicant Contact GEORGE J FRYE
Correspondent
Frye Electronics, Inc.
P.O. Box 23391
9826 SW Tigard St.
Tigard,  OR  97223
Correspondent Contact GEORGE J FRYE
Regulation Number874.1050
Classification Product Code
EWO  
Date Received07/19/1991
Decision Date 10/11/1991
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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