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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 K895590
Device Name ITE HEARING AID MODEL PA
Applicant
BEST AID, INC.
4025 TAMARACK TRAIL
CRYSTAL LAKE,  IL  60014
Applicant Contact TED JOHANNESSEN
Correspondent
BEST AID, INC.
4025 TAMARACK TRAIL
CRYSTAL LAKE,  IL  60014
Correspondent Contact TED JOHANNESSEN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received09/15/1989
Decision Date 01/04/1990
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
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