The following data is part of a premarket notification filed by Hospira, Inc with the FDA for Lifecare Pca Infusion System.
Device ID | K143612 |
510k Number | K143612 |
Device Name: | LifeCare PCA Infusion System |
Classification | Pump, Infusion, Pca |
Applicant | Hospira, Inc 275 North Field Drive Lake Forest, IL 60045 |
Contact | Tom Gutierrez |
Correspondent | Yuliya Matlin Hospira, Inc 275 North Field Drive Lake Forest, IL 60045 |
Product Code | MEA |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-19 |
Decision Date | 2016-04-08 |
Summary: | summary |