The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca Infusion System Sterile Empy Vials, Model 6021-04-03.
| Device ID | K043256 |
| 510k Number | K043256 |
| Device Name: | HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 |
| Classification | Pump, Infusion, Pca |
| Applicant | HOSPIRA, INC. 275 N. FIELD DR., BLDG. H-2 D-389 Lake Forest, IL 60045 -5045 |
| Contact | Patricia Melerski |
| Correspondent | Patricia Melerski HOSPIRA, INC. 275 N. FIELD DR., BLDG. H-2 D-389 Lake Forest, IL 60045 -5045 |
| Product Code | MEA |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-24 |
| Decision Date | 2004-12-06 |
| Summary: | summary |