The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Xenon Endoscopic Illuminator, Model Xei-300.
| Device ID | K924897 |
| 510k Number | K924897 |
| Device Name: | XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300 |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | MEDICAL DEVICES, INC. 83 HOBART ST. Hackensack, NJ 07601 |
| Contact | Samuel Dickstein |
| Correspondent | Samuel Dickstein MEDICAL DEVICES, INC. 83 HOBART ST. Hackensack, NJ 07601 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-29 |
| Decision Date | 1993-07-06 |