The following data is part of a premarket notification filed by Catheter Connections, Inc. with the FDA for Catheter Connections Dualcap.
Device ID | K093229 |
510k Number | K093229 |
Device Name: | CATHETER CONNECTIONS DUALCAP |
Classification | Cap, Device Disinfectant |
Applicant | CATHETER CONNECTIONS, INC. 25 WHITE PINE CANYON RD. Park City, UT 84060 |
Contact | Donald D Solomon |
Correspondent | Donald D Solomon CATHETER CONNECTIONS, INC. 25 WHITE PINE CANYON RD. Park City, UT 84060 |
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 | 2009-10-14 |
Decision Date | 2010-04-08 |
Summary: | summary |