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 K021480
Device Name EXTENSION SET LIGHT-SAFE, MODEL BC565
Applicant
Codan US Corp.
3511 W. Sunflower Ave.
Santa Ana,  CA  92704 -6944
Applicant Contact MARILYN R POURAZAR
Correspondent
Codan US Corp.
3511 W. Sunflower Ave.
Santa Ana,  CA  92704 -6944
Correspondent Contact MARILYN R POURAZAR
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/08/2002
Decision Date 06/27/2002
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
Predetermined Change
Control Plan Authorized		 No
-
-