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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 K872242
Device Name TYPE 6400 REAL EAR HEARING AID ANALYZER
Applicant
FRYE ELECTRONICS, INC.
P.O. BOX 23391
9826 S.W. TIGARD ST.
TIGARD,  OR  97223
Applicant Contact GEORGE J FRYE
Correspondent
FRYE ELECTRONICS, INC.
P.O. BOX 23391
9826 S.W. TIGARD ST.
TIGARD,  OR  97223
Correspondent Contact GEORGE J FRYE
Regulation Number874.3310
Classification Product Code
ETW  
Date Received06/11/1987
Decision Date 07/10/1987
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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