K843801 is an FDA 510(k) clearance for the MASON EQUIPMENT ORGANIZER & ASPEN. This device is classified as a Table, Operating-room, Manual (Class I - General Controls, product code FSE).
Submitted by Aspen Laboratories, Inc. (Englewood, US). The FDA issued a Cleared decision on October 25, 1984, 28 days after receiving the submission on September 27, 1984.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4950.
| 510(k) Number | K843801 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 1984 |
| Decision Date | October 25, 1984 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FSE — Table, Operating-room, Manual |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4950 |