510(k) K040996
- Device
- RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM
- Applicant
- GYRUS ENT L.L.C.
- 510(k) number
- K040996
- Product code
- NIX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-08-20
- Date received
- 2004-04-16
- 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
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALICIA E FARAGE
- Address
- 2925 Appling Rd. Bartlett TN US 38133 38133
Source Documents#
Other 510(k) Records For Product Code NIX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN020003 | RETROX | Auric Hearing Systems, Inc. | 2002-08-20 |
Legacy Summary#
summary
FDA Review#
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