K910783 is an FDA 510(k) clearance for the SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M. This device is classified as a Table And Attachments, Operating-room (Class I - General Controls, product code BWN).
Submitted by Smith & Nephew Equipment Group (St. Louis, US). The FDA issued a Cleared decision on April 2, 1991, 36 days after receiving the submission on February 25, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4950.
| 510(k) Number | K910783 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 1991 |
| Decision Date | April 02, 1991 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | BWN — Table And Attachments, Operating-room |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4950 |