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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 K801905
Device Name FONIX TYPE 5100 HEARING AID ANALYZER
Applicant
FRYE ELECTRONICS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
FRYE ELECTRONICS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.3310
Classification Product Code
ETW  
Date Received08/11/1980
Decision Date 08/27/1980
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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