510(k) K834094
- Device
- AUSTIN ENDOLYMPH DISPERSMENT SHUNT
- Applicant
- TREACE MEDICAL, INC.
- 510(k) number
- K834094
- Product code
- ESZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-09-20
- Date received
- 1983-11-28
- Regulation
- 874.3820
- Classification name
- Tube, Shunt, Endolymphatic
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers
- 1048735
- 1045254
- 3018094310
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00681490036115 | Pulec | MEDTRONIC XOMED, INC. | 2015-06-25 |
| 00681490035897 | Austin | MEDTRONIC XOMED, INC. | 2015-06-25 |
| 00681490035798 | Austin | MEDTRONIC XOMED, INC. | 2015-06-25 |
Legacy Summary
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FDA Review
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