The following data is part of a premarket notification filed by Svenol Andersen with the FDA for Urias Pressure Splints, & First Aid.
| Device ID | K831764 |
| 510k Number | K831764 |
| Device Name: | URIAS PRESSURE SPLINTS, & FIRST AID |
| Classification | Splint, Extremity, Inflatable, External |
| Applicant | SVENOL ANDERSEN 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FZF |
| CFR Regulation Number | 878.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-01 |
| Decision Date | 1983-09-12 |