Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name set, administration, intravascular
510(k) Number K103224
Device Name HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING
Applicant
HOSPIRA, INC.
375 NORTH FIELD DR.
BLDG. 2
LAKE FOREST,  IL  60045 -5045
Applicant Contact KAREN KEENER
Correspondent
HOSPIRA, INC.
375 NORTH FIELD DR.
BLDG. 2
LAKE FOREST,  IL  60045 -5045
Correspondent Contact KAREN KEENER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/01/2010
Decision Date 01/07/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-