The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Hospira Plum A+ Infusion Pump System V11.5, Hospira Plum A+ 3 Infusion Pump System, V11.5.
Device ID | K052052 |
510k Number | K052052 |
Device Name: | HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5 |
Classification | Pump, Infusion |
Applicant | HOSPIRA, INC. 275 N. FIELD DR., BLDG. H-2 D-389 Lake Forest, IL 60045 -5045 |
Contact | Patricia Melerski |
Correspondent | Patricia Melerski HOSPIRA, INC. 275 N. FIELD DR., BLDG. H-2 D-389 Lake Forest, IL 60045 -5045 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-29 |
Decision Date | 2005-08-24 |
Summary: | summary |