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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 K123962
Model ALPHA (M)
Device Name OTOMAG BONE CONDUCTION HEARING SYSTEM
Original Applicant
SOPHONO, INC
5744 central avenue #100
boulder,  CO  80301
Original Contact krista b traynor
Regulation Number874.3300
Classification Product Code
LXB  
Date Received12/26/2012
Decision Date 04/08/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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