The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Flush Syringe Filled With 0.9% Sodium Chloride.
| Device ID | K090882 |
| 510k Number | K090882 |
| Device Name: | FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE |
| Classification | Saline, Vascular Access Flush |
| Applicant | HOSPIRA, INC. 275 NORTH FIELD DR. D-389, BLDG., H2 Lake Forest, IL 60045 |
| Contact | Keith Dunn |
| Correspondent | Keith Dunn HOSPIRA, INC. 275 NORTH FIELD DR. D-389, BLDG., H2 Lake Forest, IL 60045 |
| Product Code | NGT |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-31 |
| Decision Date | 2010-04-23 |
| Summary: | summary |