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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 K904731
Device Name QUALITONE ITE GENESIS
Applicant
QUALITONE
4931 WEST 35TH ST.
MINNEAPOLIS,  MN  55416
Applicant Contact A BROWN
Correspondent
QUALITONE
4931 WEST 35TH ST.
MINNEAPOLIS,  MN  55416
Correspondent Contact A BROWN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/17/1990
Decision Date 12/17/1990
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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