FDA 510(k) Application Details - DEN020003

Device Classification Name Hearing Aid, Air Conduction, Transcutaneous System

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510(K) Number DEN020003
Device Name Hearing Aid, Air Conduction, Transcutaneous System
Applicant AURIC HEARING SYSTEMS, INC.
8 FENNO WAY
NAHANT, MA 01908 US
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Contact DAVID J NAVAROLI
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Regulation Number 874.3950

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Classification Product Code NIX
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Date Received 06/21/2002
Decision Date 08/20/2002
Decision DENG -
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Type Post-NSE
Reviewed By Third Party N
Expedited Review



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