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 K873173
Device Name MEDRAD MRI INJECTION SYSTEM
Applicant
Medrad, Inc.
271 Kappa Dr.
Pittsburgh,  PA  15238
Applicant Contact RUEY C DEMPSEY
Correspondent
Medrad, Inc.
271 Kappa Dr.
Pittsburgh,  PA  15238
Correspondent Contact RUEY C DEMPSEY
Regulation Number870.1650
Classification Product Code
DXT  
Date Received08/12/1987
Decision Date 02/05/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-