The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Austin Endolymph Dispersment Shunt.
| Device ID | K834094 |
| 510k Number | K834094 |
| Device Name: | AUSTIN ENDOLYMPH DISPERSMENT SHUNT |
| Classification | Tube, Shunt, Endolymphatic |
| Applicant | TREACE MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ESZ |
| CFR Regulation Number | 874.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-28 |
| Decision Date | 1984-09-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00681490036115 | K834094 | 000 |
| 00681490035897 | K834094 | 000 |
| 00681490035798 | K834094 | 000 |