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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 K093006
Device Name FONIX ,MODEL 8000
Applicant
Frye Electronics, Inc.
9826 SW Tigard St.
Tigard,  OR  97223
Applicant Contact KRISTINA FRYE
Correspondent
Frye Electronics, Inc.
9826 SW Tigard St.
Tigard,  OR  97223
Correspondent Contact KRISTINA FRYE
Regulation Number874.3310
Classification Product Code
ETW  
Date Received09/28/2009
Decision Date 12/30/2009
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
Predetermined Change
Control Plan Authorized		 No
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