The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Hospira Plum A+ Infusion Pump, Model 12391.
Device ID | K070398 |
510k Number | K070398 |
Device Name: | HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391 |
Classification | Pump, Infusion |
Applicant | HOSPIRA, INC. 275 NORTH FIELD DR. Lake Forest, IL 60045 |
Contact | Nicohl R Wilding |
Correspondent | Nicohl R Wilding HOSPIRA, INC. 275 NORTH FIELD DR. 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 | 2007-02-12 |
Decision Date | 2007-04-24 |
Summary: | summary |