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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 K910705
Device Name ACTIVE MODEL AHX HELIX ITE HEARING AID
Applicant
ACTIVE ELECTRONICS, INC.
1461 92ND AVENUE NE
BLAINE,  MN  55449
Applicant Contact DALE S NORDBY
Correspondent
ACTIVE ELECTRONICS, INC.
1461 92ND AVENUE NE
BLAINE,  MN  55449
Correspondent Contact DALE S NORDBY
Regulation Number874.3300
Classification Product Code
ESD  
Date Received02/20/1991
Decision Date 02/28/1991
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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