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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 K892803
Device Name PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911
Applicant
UNITED HEARING SYSTEMS, INC.
P.O BOX 122
731B NORWICH ROAD
PLAINFIELD,  CT  06374
Applicant Contact RALPH CAMPAGNA
Correspondent
UNITED HEARING SYSTEMS, INC.
P.O BOX 122
731B NORWICH ROAD
PLAINFIELD,  CT  06374
Correspondent Contact RALPH CAMPAGNA
Regulation Number874.3300
Classification Product Code
ESD  
Date Received04/17/1989
Decision Date 06/22/1989
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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