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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 K121793
Device Name AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON
Original Applicant
AUDIFON-USA INC.
403 chairman ct., ste. 1
debary,  FL  32713
Original Contact jane e perrone
Regulation Number874.3300
Classification Product Code
LXB  
Date Received06/19/2012
Decision Date 11/01/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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