TRACE MODEL #'S 840, 841, 842, 845
Device Facts
| Record ID | K925145 |
|---|---|
| Device Name | TRACE MODEL #'S 840, 841, 842, 845 |
| Applicant | Trace Medical Equipment, Inc. |
| Product Code | FYH · General, Plastic Surgery |
| Decision Date | May 19, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.3910 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.
