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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
510(k) Number K853170
Device Name INTERNATIONAL MODEL SC CUSTOM IN THE EAR HEARG AID
Applicant
INT'L HEARING AIDS, INC.
p.o. box 255
hopkins,  MN  55343
Applicant Contact patricia j bing
Correspondent
INT'L HEARING AIDS, INC.
p.o. box 255
hopkins,  MN  55343
Correspondent Contact patricia j bing
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/30/1985
Decision Date 10/04/1985
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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