The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for T-tube Inserter.
| Device ID | K831590 |
| 510k Number | K831590 |
| Device Name: | T-TUBE INSERTER |
| Classification | Source, Carrier, Fiberoptic Light |
| Applicant | TREACE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EQH |
| CFR Regulation Number | 874.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-17 |
| Decision Date | 1983-06-15 |