FDA 510(k) Application Details - K020333

Device Classification Name Injector And Syringe, Angiographic

  More FDA Info for this Device
510(K) Number K020333
Device Name Injector And Syringe, Angiographic
Applicant ATRION MEDICAL PRODUCTS, INC.
1426 CURT FRANCIS RD.
ARAB, AL 35016 US
Other 510(k) Applications for this Company
Contact DAN CLARK
Other 510(k) Applications for this Contact
Regulation Number 870.1650

  More FDA Info for this Regulation Number
Classification Product Code DXT
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 01/31/2002
Decision Date 04/25/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact