The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Hospira Extension Sets.
Device ID | K151969 |
510k Number | K151969 |
Device Name: | Hospira Extension Sets |
Classification | Set, Administration, Intravascular |
Applicant | Hospira, Inc. 375 Field Drive Lake Forest, IL 60045 |
Contact | Charles Neitzel |
Correspondent | Charles Neitzel Hospira, Inc. 375 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 | 2015-07-16 |
Decision Date | 2016-01-19 |
Summary: | summary |