RETROX
FDA 510(k) clearance DEN020003 · decided 2002-08-20
Clearance details
- K-number
- DEN020003
- Device name
- RETROX
- Applicant
- Auric Hearing Systems, Inc.
- Decision
- Unknown
- Date received
- 2002-06-21
- Decision date
- 2002-08-20
- Days to decision
- 60 days
- Clearance type
- Post-NSE
- Product code
- NIX
- Device class
- 2
- Regulation number
- 874.3950
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Nahant, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM (K040996) | Gyrus Ent LLC | 2004-08-20 |
Recalls involving this device
No recalls on record reference this clearance.