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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, bone conduction
510(k) Number K955713
Device Name NOBELPHARMA BONE ANCHORED HEARING AID
Applicant
NOBELPHARMA USA, INC.
777 OAKMONT LN.
SUITE 100
WESTMONT,  IL  60559
Applicant Contact MARY EDWARDS
Correspondent
NOBELPHARMA USA, INC.
777 OAKMONT LN.
SUITE 100
WESTMONT,  IL  60559
Correspondent Contact MARY EDWARDS
Regulation Number874.3302
Classification Product Code
LXB  
Date Received12/18/1995
Decision Date 08/09/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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