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 |