The following data is part of a premarket notification filed by Hospira, Inc with the FDA for Hospira Sapphire Sets.
| Device ID | K160492 |
| 510k Number | K160492 |
| Device Name: | Hospira Sapphire Sets |
| Classification | Accessories, Pump, Infusion |
| Applicant | Hospira, Inc 375 North Field Drive Lake Forest, IL 60045 |
| Contact | David Blonski |
| Correspondent | David Blonski Hospira, Inc 375 North Field Drive Lake Forest, IL 60045 |
| Product Code | MRZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-22 |
| Decision Date | 2016-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20887787009235 | K160492 | 000 |