The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lumenon Xenon Light Source.
| Device ID | K992050 |
| 510k Number | K992050 |
| Device Name: | LUMENON XENON LIGHT SOURCE |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 -2480 |
| Contact | Trevor Byrd |
| Correspondent | Trevor Byrd WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 -2480 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-17 |
| Decision Date | 1999-09-14 |
| Summary: | summary |