• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K042936
Device Name SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE
Original Applicant
BAXTER HEALTHCARE CORP.
route 120 and wilson rd.
round lake,  IL  60073
Original Contact nanette hedden
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/25/2004
Decision Date 11/26/2004
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-