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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 K861971
Device Name XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL
Applicant
Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Applicant Contact DON BRUCE
Correspondent
Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Correspondent Contact DON BRUCE
Regulation Number874.3302
Classification Product Code
LXB  
Date Received05/21/1986
Decision Date 05/30/1986
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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