The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Iv Administration.
Device ID | K142622 |
510k Number | K142622 |
Device Name: | IV Administration |
Classification | Set, Administration, Intravascular |
Applicant | HOSPIRA, INC. 375 N. FIELD DRIVE Lake Forest, IL 60045 |
Contact | David Blonski |
Correspondent | David Blonski HOSPIRA, INC. 375 N. 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 | 2014-09-16 |
Decision Date | 2015-01-15 |
Summary: | summary |