| 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 |
|