The following data is part of a premarket notification filed by Vitreo Dynamics, Co. with the FDA for Illuminating Infusion Contact Lens For Eye Surgery.
Device ID | K874591 |
510k Number | K874591 |
Device Name: | ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY |
Classification | Lens, Contact (polymethylmethacrylate) |
Applicant | VITREO DYNAMICS, CO. 684 CAPEWOOD PLACE Southaven, MS 38671 |
Contact | Jeff Freeman |
Correspondent | Jeff Freeman VITREO DYNAMICS, CO. 684 CAPEWOOD PLACE Southaven, MS 38671 |
Product Code | HPX |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-09 |
Decision Date | 1988-05-03 |