The following data is part of a premarket notification filed by Skytron, Div. The Kmw Group, Inc. with the FDA for Skytron Universe Series Surgical Lights.
| Device ID | K900211 |
| 510k Number | K900211 |
| Device Name: | SKYTRON UNIVERSE SERIES SURGICAL LIGHTS |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | SKYTRON, DIV. THE KMW GROUP, INC. 5000 36TH ST., S.E. Grand Rapids, MI 49512 |
| Contact | Larry J Purcey |
| Correspondent | Larry J Purcey SKYTRON, DIV. THE KMW GROUP, INC. 5000 36TH ST., S.E. Grand Rapids, MI 49512 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-17 |
| Decision Date | 1990-03-19 |