The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Handi-tray.
| Device ID | K823438 |
| 510k Number | K823438 |
| Device Name: | HANDI-TRAY |
| Classification | Tray, Surgical, Instrument |
| Applicant | TREACE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FSM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-16 |
| Decision Date | 1983-01-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HANDI-TRAY 71518283 0518538 Dead/Expired |
DREXEL FURNITURE COMPANY 1947-02-28 |