The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Hospira Blood Set.
Device ID | K143087 |
510k Number | K143087 |
Device Name: | Hospira Blood Set |
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 | 2014-10-27 |
Decision Date | 2015-03-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20887787008832 | K143087 | 000 |