The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for System 3000 Xenon Videolap Light.
| Device ID | K923210 |
| 510k Number | K923210 |
| Device Name: | SYSTEM 3000 XENON VIDEOLAP LIGHT |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Contact | Todd J Polk |
| Correspondent | Todd J Polk CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-01 |
| Decision Date | 1992-10-05 |