The following data is part of a premarket notification filed by Trace Medical Equipment, Inc. with the FDA for Trace Model #'s 840, 841, 842, 845.
| Device ID | K925145 |
| 510k Number | K925145 |
| Device Name: | TRACE MODEL #'S 840, 841, 842, 845 |
| Classification | Splint, Extremity, Noninflatable, External, Sterile |
| Applicant | TRACE MEDICAL EQUIPMENT, INC. 5000 VARSITY DR. Lisle, IL 60532 |
| Contact | John Novack |
| Correspondent | John Novack TRACE MEDICAL EQUIPMENT, INC. 5000 VARSITY DR. Lisle, IL 60532 |
| Product Code | FYH |
| CFR Regulation Number | 878.3910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-13 |
| Decision Date | 1993-05-19 |