The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Lifecare Pca Infusion System With Hospira Mednet Software.
| Device ID | K042800 |
| 510k Number | K042800 |
| Device Name: | LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE |
| Classification | Pump, Infusion, Pca |
| Applicant | HOSPIRA, INC. 275 N. FIELD DR., BLDG. H-2 D-389 Lake Forest, IL 60045 -5045 |
| Contact | Thomas Kozma |
| Correspondent | Neil E Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | MEA |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-10-08 |
| Decision Date | 2004-10-18 |
| Summary: | summary |