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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 K880273
Device Name WIDEX HEARING AID MODEL C1
Applicant
WIDEX HEARING AID CO., INC.
35-23 24TH ST.
LONG ISLAND CITY,  NY  11106
Correspondent
WIDEX HEARING AID CO., INC.
35-23 24TH ST.
LONG ISLAND CITY,  NY  11106
Regulation Number874.3300
Classification Product Code
ESD  
Date Received01/22/1988
Decision Date 03/14/1988
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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