The following data is part of a premarket notification filed by Catheter Connections, Inc. with the FDA for Catheter Connections' Dualcap Duo.
Device ID | K112985 |
510k Number | K112985 |
Device Name: | CATHETER CONNECTIONS' DUALCAP DUO |
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 | 2011-10-06 |
Decision Date | 2011-11-09 |
Summary: | summary |