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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 K953872
Device Name SECOND EAR BONE CONDUCTION HEARING AID
Applicant
Wordcomp International Communication Group (Wicg)
1000 Bunnett Ave.
Suite 450
Concord,  CA  94520
Applicant Contact DAVID W SCHLERF
Correspondent
Wordcomp International Communication Group (Wicg)
1000 Bunnett Ave.
Suite 450
Concord,  CA  94520
Correspondent Contact DAVID W SCHLERF
Regulation Number874.3302
Classification Product Code
LXB  
Date Received08/17/1995
Decision Date 04/12/1996
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
Predetermined Change
Control Plan Authorized		 No
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