The following data is part of a premarket notification filed by Trace Medical Equipment, Inc. with the FDA for Trace Model# 840, 841,842 & 845 Arm Board.
| Device ID | K925502 |
| 510k Number | K925502 |
| Device Name: | TRACE MODEL# 840, 841,842 & 845 ARM BOARD |
| Classification | Device, Intravascular Catheter Securement |
| Applicant | TRACE MEDICAL EQUIPMENT, INC. 5000 VARSITY DR. Lisle, IL 60532 |
| Contact | John G Novack |
| Correspondent | John G Novack TRACE MEDICAL EQUIPMENT, INC. 5000 VARSITY DR. Lisle, IL 60532 |
| Product Code | KMK |
| CFR Regulation Number | 880.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-30 |
| Decision Date | 1993-01-12 |