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 |