K831764 is an FDA 510(k) clearance for the URIAS PRESSURE SPLINTS, & FIRST AID. This device is classified as a Splint, Extremity, Inflatable, External (Class I - General Controls, product code FZF).
Submitted by Svenol Andersen (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983, 103 days after receiving the submission on June 1, 1983.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3900.
| 510(k) Number | K831764 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 1983 |
| Decision Date | September 12, 1983 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FZF — Splint, Extremity, Inflatable, External |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.3900 |