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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 K861571
Device Name TYPE 6500 HEARING AID ANALYZER
Original Applicant
FRYE ELECTRONICS, INC.
p.o. box 23391
9826 s.w. tigard st.
tigard,  OR  97223
Original Contact george j frye
Regulation Number874.3310
Classification Product Code
ETW  
Date Received04/28/1986
Decision Date 05/30/1986
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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