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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 K926085
Device Name WIDEX MODEL D16
Applicant
WIDEX HEARING AID CO., INC.
35-23 24TH ST.
LONG ISLAND CITY,  NY  11106
Applicant Contact RON MELTSNER
Correspondent
WIDEX HEARING AID CO., INC.
35-23 24TH ST.
LONG ISLAND CITY,  NY  11106
Correspondent Contact RON MELTSNER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received12/02/1992
Decision Date 02/02/1993
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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