The following data is part of a premarket notification filed by Catheter Connections, Inc. with the FDA for Dualcap Iv Pole Strips(disinfectant Caps For Male Luers).
Device ID | K142399 |
510k Number | K142399 |
Device Name: | DualCap IV Pole Strips(Disinfectant Caps For Male Luers) |
Classification | Cap, Device Disinfectant |
Applicant | CATHETER CONNECTIONS, INC. 2455 E Parleys Way - Suite 150 Salt Lake City, UT 84109 |
Contact | Donald D Soloman |
Correspondent | Donald D Soloman 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 | 2014-08-27 |
Decision Date | 2014-11-19 |
Summary: | summary |