The following data is part of a premarket notification filed by Coopervision Surgical with the FDA for Xenon Light Source And Accessories.
| Device ID | K921390 |
| 510k Number | K921390 |
| Device Name: | XENON LIGHT SOURCE AND ACCESSORIES |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | COOPERVISION SURGICAL 15 FOREST PKWY. Shelton, CT 06484 |
| Contact | Clifford F Potocky |
| Correspondent | Clifford F Potocky COOPERVISION SURGICAL 15 FOREST PKWY. Shelton, CT 06484 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-23 |
| Decision Date | 1992-07-27 |