The following data is part of a premarket notification filed by Catheter Connections, Inc. with the FDA for Dualcap.
Device ID | K142806 |
510k Number | K142806 |
Device Name: | DualCap |
Classification | Cap, Device Disinfectant |
Applicant | CATHETER CONNECTIONS, INC. 2455 E Parleys Way - Suite 150 Salt Lake City, UT 84109 |
Contact | Mark Endo |
Correspondent | Mark Endo CATHETER CONNECTIONS, INC. 2455 E Parleys Way - Suite 150 Salt Lake City, UT 84109 |
Product Code | QBP |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-29 |
Decision Date | 2015-05-22 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DUALCAP 77705452 4023166 Live/Registered |
MERIT MEDICAL SYSTEMS, INC. 2009-04-02 |