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 Injector And Syringe, Angiographic
510(k) Number K073592
Device Name OPTISTAR ELITE INJECTION SYSTEM
Applicant
Mallinckrodt Inc., Liebel-Flarsheim Business
2111 E. Galbraith Rd.
Cincinnati,  OH  45237
Applicant Contact DALE MOORE
Correspondent
Mallinckrodt Inc., Liebel-Flarsheim Business
2111 E. Galbraith Rd.
Cincinnati,  OH  45237
Correspondent Contact DALE MOORE
Regulation Number870.1650
Classification Product Code
DXT  
Date Received12/20/2007
Decision Date 05/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-