The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Hospira Primary Sets.
| Device ID | K143015 |
| 510k Number | K143015 |
| Device Name: | Hospira Primary Sets |
| Classification | Set, Administration, Intravascular |
| Applicant | Hospira, Inc. 375 North Field Drive Lake Forest, IL 60045 |
| Contact | Anju Kurian |
| Correspondent | Anju Kurian Hospira, Inc. 375 North Field Drive Lake Forest, IL 60045 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-20 |
| Decision Date | 2015-02-25 |
| Summary: | summary |