The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Hospira Extension Set.
Device ID | K142433 |
510k Number | K142433 |
Device Name: | Hospira Extension Set |
Classification | Set, Administration, Intravascular |
Applicant | Hospira, Inc. 375 Field Drive Lake Forest, IL 60045 |
Contact | David Blonski |
Correspondent | David Blonski 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 | 2014-08-29 |
Decision Date | 2014-12-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10887709102016 | K142433 | 000 |