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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Air-Conduction, Prescription
510(k) Number K913366
Device Name IN-THE-EAR HEARING AIDS
Applicant
Fenwick Hearing Instruments
2188 SW Park Pl.,
Suite 101
Portland,  OR  97205
Applicant Contact JAMES A FENWICK
Correspondent
Fenwick Hearing Instruments
2188 SW Park Pl.,
Suite 101
Portland,  OR  97205
Correspondent Contact JAMES A FENWICK
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/29/1991
Decision Date 11/05/1991
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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