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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 K881382
Device Name XOMED AUDIANT BONE CONDUCTOR
Applicant
Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216 -0980
Applicant Contact DONALD R BRUCE
Correspondent
Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216 -0980
Correspondent Contact DONALD R BRUCE
Regulation Number874.3302
Classification Product Code
LXB  
Date Received04/01/1988
Decision Date 06/21/1988
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
Predetermined Change
Control Plan Authorized		 No
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