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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 K944838
Device Name WIDEX MODEL LX-ITE
Applicant
WIDEX HEARING AID CO., INC.
35-53 24TH ST.
LONG ISLAND CITY,  NY  11106
Applicant Contact RON MELTSNER
Correspondent
WIDEX HEARING AID CO., INC.
35-53 24TH ST.
LONG ISLAND CITY,  NY  11106
Correspondent Contact RON MELTSNER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received09/30/1994
Decision Date 10/20/1994
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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