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 K984088
Device Name OPTISTAR MR INJECTOR SYSTEM
Applicant
Mallinckrodt Inc., Liebel-Flarsheim Business
2111 E. Galbraith Rd.
Cincinnati,  OH  45237
Applicant Contact BRIDGET DRAKE
Correspondent
Mallinckrodt Inc., Liebel-Flarsheim Business
2111 E. Galbraith Rd.
Cincinnati,  OH  45237
Correspondent Contact BRIDGET DRAKE
Regulation Number870.1650
Classification Product Code
DXT  
Date Received11/16/1998
Decision Date 12/06/1999
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
Recalls CDRH Recalls
-
-