510(k) DEN020003
- Device
- RETROX
- Applicant
- Auric Hearing Systems, Inc.
- 510(k) number
- DEN020003
- Product code
- NIX
- Decision
- Unknown (DENG)
- Decision date
- 2002-08-20
- Date received
- 2002-06-21
- Regulation
- 874.3950
- Classification name
- Hearing Aid, Air Conduction, Transcutaneous System
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- DAVID J NAVAROLI
- Address
- 8 Fenno Way Nahant MA US 01908 01908
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NIX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K040996 | RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM | Gyrus Ent LLC | 2004-08-20 |