The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Lifeshield Latex-free Gravitech Flow Controller I.v. Sets, Models 17528, 17527, 17525 & 17526.
| Device ID | K063239 |
| 510k Number | K063239 |
| Device Name: | LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526 |
| Classification | Tubing, Fluid Delivery |
| Applicant | HOSPIRA, INC. 275 NORTH FIELD DR. DEPT. 389, BLDG. H2 Lake Forest, IL 60045 |
| Contact | Diane Rennpferd |
| Correspondent | Diane Rennpferd HOSPIRA, INC. 275 NORTH FIELD DR. DEPT. 389, BLDG. H2 Lake Forest, IL 60045 |
| Product Code | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-26 |
| Decision Date | 2006-12-11 |
| Summary: | summary |