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 K033301
Device Name IV ADMINISTRATION AND CONNECT SETS
Applicant
CODAN US CORP.
3511 WEST SUNFLOWER AVE.
SANTA ANA,  CA  92704 -6944
Applicant Contact ROHIT PATEL
Correspondent
CODAN US CORP.
3511 WEST SUNFLOWER AVE.
SANTA ANA,  CA  92704 -6944
Correspondent Contact ROHIT PATEL
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/14/2003
Decision Date 03/04/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-