The following data is part of a premarket notification filed by Escalon Trek Medical with the FDA for Vitlite (tr7700).
| Device ID | K963417 |
| 510k Number | K963417 |
| Device Name: | VITLITE (TR7700) |
| Classification | Endoilluminator |
| Applicant | ESCALON TREK MEDICAL 822 SWAN DR. Mukwonago, WI 53149 |
| Contact | Ronald L Hueneke |
| Correspondent | Ronald L Hueneke ESCALON TREK MEDICAL 822 SWAN DR. Mukwonago, WI 53149 |
| Product Code | MPA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-30 |
| Decision Date | 1996-12-20 |