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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 K100193
Device Name OTOMAG BONE CONDUCTION HEARING SYSTEM
Applicant
SOPHONO, INC
555 ZANG STREET
SUITE 100
LAKEWOOD,  CO  80228
Applicant Contact Mary Armstrong
Correspondent
SOPHONO, INC
555 ZANG STREET
SUITE 100
LAKEWOOD,  CO  80228
Correspondent Contact Mary Armstrong
Regulation Number874.3302
Classification Product Code
LXB  
Date Received01/22/2010
Decision Date 05/18/2010
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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