The following data is part of a premarket notification filed by Vidacare Corporation with the FDA for Ez-io.
Device ID | K052408 |
510k Number | K052408 |
Device Name: | EZ-IO |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | VIDACARE CORPORATION 3722 AVE. SAUSALITO Irvine, CA 92606 |
Contact | Grace Holland |
Correspondent | Grace Holland VIDACARE CORPORATION 3722 AVE. SAUSALITO Irvine, CA 92606 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-09-01 |
Decision Date | 2005-11-17 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EZ-IO 87211623 5269420 Live/Registered |
Teleflex Medical Devices S.Ã r.l. 2016-10-21 |
EZ-IO 85499983 4183350 Dead/Cancelled |
TELEFLEX MEDICAL DEVICES S.Ã R.L. 2011-12-20 |
EZ-IO 78405834 2984250 Dead/Cancelled |
VIDACARE LLC 2004-04-21 |