The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Lifeshield Latex-free Microbore Extension Set, Model 14949 And Others.
Device ID | K052722 |
510k Number | K052722 |
Device Name: | LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS |
Classification | Set, Administration, Intravascular |
Applicant | HOSPIRA, INC. 275 NORTH FIELD DR. Lake Forest, IL 60045 |
Contact | Thomas Kozma |
Correspondent | Thomas Kozma HOSPIRA, INC. 275 NORTH FIELD DR. Lake Forest, IL 60045 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Se - With Limitations (SESU) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-09-29 |
Decision Date | 2005-11-02 |
Summary: | summary |