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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 K843789
Device Name ULTRA & ULTRA MINATURE
Applicant
QUALITONE
4931 WEST 35TH ST.
MINNEAPOLIS,  MN  55416
Applicant Contact JAMES C ANDERSON
Correspondent
QUALITONE
4931 WEST 35TH ST.
MINNEAPOLIS,  MN  55416
Correspondent Contact JAMES C ANDERSON
Regulation Number874.3300
Classification Product Code
ESD  
Date Received09/27/1984
Decision Date 12/13/1984
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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