The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model 13086; Pain Management, Model 13088.
| Device ID | K060806 |
| 510k Number | K060806 |
| Device Name: | HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088 |
| Classification | Pump, Infusion |
| Applicant | HOSPIRA, INC. 275 N. FIELD DR., BLDG. H-2 DEPT. 389 Lake Forest, IL 60045 |
| Contact | Patricia Melerski |
| Correspondent | Patricia Melerski HOSPIRA, INC. 275 N. FIELD DR., BLDG. H-2 DEPT. 389 Lake Forest, IL 60045 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-24 |
| Decision Date | 2006-04-21 |
| Summary: | summary |