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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 K102199
FOIA Releasable 510(k) K102199
Device Name OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)
Applicant
Sophono, Inc.
555 Zang St., Suite 100
Lakewood,  CO  80228
Applicant Contact CLAY ANSELMO
Correspondent
Sophono, Inc.
555 Zang St., Suite 100
Lakewood,  CO  80228
Correspondent Contact CLAY ANSELMO
Regulation Number874.3302
Classification Product Code
LXB  
Date Received08/04/2010
Decision Date 05/23/2011
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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