The following data is part of a premarket notification filed by Contec Medical Vision, Ltd. with the FDA for Xenon Light Source Model Ls6000.
| Device ID | K981804 |
| 510k Number | K981804 |
| Device Name: | XENON LIGHT SOURCE MODEL LS6000 |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | CONTEC MEDICAL VISION, LTD. 1109 STURBRIDGE RD. Fallston, MD 21047 |
| Contact | Albert E Austin |
| Correspondent | Albert E Austin CONTEC MEDICAL VISION, LTD. 1109 STURBRIDGE RD. Fallston, MD 21047 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-21 |
| Decision Date | 1998-07-24 |
| Summary: | summary |