The following data is part of a premarket notification filed by Smith & Nephew Equipment Group with the FDA for Shampaine Model 3800 Or Muranaka Model Or-604m.
| Device ID | K910783 |
| 510k Number | K910783 |
| Device Name: | SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M |
| Classification | Table And Attachments, Operating-room |
| Applicant | SMITH & NEPHEW EQUIPMENT GROUP 1920 A. JEFFERSON AVE. St. Louis, MO 63104 |
| Contact | Kevin Randich |
| Correspondent | Kevin Randich SMITH & NEPHEW EQUIPMENT GROUP 1920 A. JEFFERSON AVE. St. Louis, MO 63104 |
| Product Code | BWN |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-25 |
| Decision Date | 1991-04-02 |