The following data is part of a premarket notification filed by Eyevi & Co. with the FDA for Eyewi Ankors.
Device ID | K800726 |
510k Number | K800726 |
Device Name: | EYEWI ANKORS |
Classification | Device, Intravascular Catheter Securement |
Applicant | EYEVI & CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KMK |
CFR Regulation Number | 880.5210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-04-01 |
Decision Date | 1980-05-08 |