The following data is part of a premarket notification filed by Eagle Vision, Inc. with the FDA for Monocanalicular Stents, Lacrimal Intubation Sets.
Device ID | K030353 |
510k Number | K030353 |
Device Name: | MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS |
Classification | Lacrimal Stents And Intubation Sets |
Applicant | EAGLE VISION, INC. 8500 WOLF LAKE DR. SUITE 110 Memphis, TN 38133 |
Contact | Billy Hannaford |
Correspondent | Billy Hannaford EAGLE VISION, INC. 8500 WOLF LAKE DR. SUITE 110 Memphis, TN 38133 |
Product Code | OKS |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-02-03 |
Decision Date | 2003-04-25 |
Summary: | summary |