The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Infusion Sets.
| Device ID | K103344 |
| 510k Number | K103344 |
| Device Name: | INFUSION SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | HOSPIRA, INC. 275 NORTH FIELD DR. Lake Forest, IL 60045 |
| Contact | Rebecca Andersen |
| Correspondent | Rebecca Andersen HOSPIRA, INC. 275 NORTH FIELD DR. Lake Forest, IL 60045 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-15 |
| Decision Date | 2010-12-10 |
| Summary: | summary |