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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 K963047
Device Name AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY)
Applicant
FENWICK HEARING INSTRUMENTS
2188 S.W. PARK PLACE,
SUITE 101
PORTLAND,  OR  97205
Applicant Contact JAMES A FENWICK III
Correspondent
FENWICK HEARING INSTRUMENTS
2188 S.W. PARK PLACE,
SUITE 101
PORTLAND,  OR  97205
Correspondent Contact JAMES A FENWICK III
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/29/1996
Decision Date 09/10/1996
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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