The following data is part of a premarket notification filed by Catheter Connections, Inc. with the FDA for Catheter Connections' Dark Blue Dualcap For Male Luers.
| Device ID | K123967 |
| 510k Number | K123967 |
| Device Name: | CATHETER CONNECTIONS' DARK BLUE DUALCAP 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 Solomon |
| Correspondent | Donald D Solomon 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-26 |
| Decision Date | 2013-01-22 |
| Summary: | summary |