The following data is part of a premarket notification filed by Vistek Corp. with the FDA for Vls 5300 300w Xenon Light Source.
| Device ID | K904681 |
| 510k Number | K904681 |
| Device Name: | VLS 5300 300W XENON LIGHT SOURCE |
| Classification | Illuminator, Fiberoptic, Surgical Field |
| Applicant | VISTEK CORP. 70 SANTA FELICIA DR. Goleta, CA 93117 |
| Contact | Richard Mullarky |
| Correspondent | Richard Mullarky VISTEK CORP. 70 SANTA FELICIA DR. Goleta, CA 93117 |
| Product Code | HBI |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-15 |
| Decision Date | 1990-12-18 |