The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Hospira Infusion Blood Sets.
| Device ID | K101677 |
| 510k Number | K101677 |
| Device Name: | HOSPIRA INFUSION BLOOD SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | HOSPIRA, INC. 375 N FIELD DRIVE Lake Forest, IL 60045 |
| Contact | Karen Keener |
| Correspondent | Karen Keener HOSPIRA, INC. 375 N FIELD DRIVE 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 | 2010-06-15 |
| Decision Date | 2010-08-11 |
| Summary: | summary |