The following data is part of a premarket notification filed by Skytron, Div. The Kmw Group, Inc. with the FDA for Skytron Elite Surgical Tables.
| Device ID | K811311 |
| 510k Number | K811311 |
| Device Name: | SKYTRON ELITE SURGICAL TABLES |
| Classification | Lamp, Surgical, Incandescent |
| Applicant | SKYTRON, DIV. THE KMW GROUP, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GBC |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-11 |
| Decision Date | 1981-06-02 |