FDA 510(k) Application Details - K121793

Device Classification Name Hearing Aid, Bone Conduction

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510(K) Number K121793
Device Name Hearing Aid, Bone Conduction
Applicant AUDIFON-USA INC.
403 CHAIRMAN CT., STE. 1
DEBARY, FL 32713 US
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Contact JANE E PERRONE
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Regulation Number 874.3300

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Classification Product Code LXB
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Date Received 06/19/2012
Decision Date 11/01/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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