K964273 is an FDA 510(k) clearance for the DURA-BOARD ARMBOARD. This device is classified as a Table, Operating-room, Electrical (Class I — General Controls, product code GDC).
Submitted by Allen Medical Systems, Inc. (Cleveland, US). The FDA issued a Cleared decision on January 8, 1997, 72 days after receiving the submission on October 28, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4960.
| 510(k) Number | K964273 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 28, 1996 |
| Decision Date | January 08, 1997 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GDC — Table, Operating-room, Electrical |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4960 |