The following data is part of a premarket notification filed by Hospira, Inc with the FDA for Extension Sets.
Device ID | K142974 |
510k Number | K142974 |
Device Name: | Extension Sets |
Classification | Set, Administration, Intravascular |
Applicant | Hospira, Inc 375 North Field Drive Lake Forest, IL 60045 |
Contact | David Blonski |
Correspondent | David Blonski Hospira, Inc 375 North Field Drive Lake Forest, IL 60045 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-14 |
Decision Date | 2015-01-09 |
Summary: | summary |