Device Classification Name |
Hearing Aid, Air Conduction, Transcutaneous System
More FDA Info for this Device |
510(K) Number |
DEN020003 |
Device Name |
Hearing Aid, Air Conduction, Transcutaneous System |
Applicant |
AURIC HEARING SYSTEMS, INC.
8 FENNO WAY
NAHANT, MA 01908 US
Other 510(k) Applications for this Company
|
Contact |
DAVID J NAVAROLI
Other 510(k) Applications for this Contact |
Regulation Number |
874.3950
More FDA Info for this Regulation Number |
Classification Product Code |
NIX
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
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 |
|