K890309 is an FDA 510(k) clearance for the MALIS SURGICAL STOOL. This device is classified as a Stool, Operating-room (Class I - General Controls, product code FZM).
Submitted by Valley Forge Scientific Corp. (Valley Forge, US). The FDA issued a Cleared decision on February 14, 1989, 22 days after receiving the submission on January 23, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4950.
| 510(k) Number | K890309 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1989 |
| Decision Date | February 14, 1989 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FZM — Stool, Operating-room |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4950 |