The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Hospira Extension Set, Hospira Primary Set.
| Device ID | K161036 |
| 510k Number | K161036 |
| Device Name: | Hospira Extension Set, Hospira Primary Set |
| Classification | Set, Administration, Intravascular |
| Applicant | HOSPIRA, INC. 375 FIELD DRIVE Lake Forest, IL 60045 |
| Contact | Charles Neitzel |
| Correspondent | Charles Neitzel HOSPIRA, INC. 375 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 | 2016-04-13 |
| Decision Date | 2017-01-06 |
| Summary: | summary |