FDA 510(k) Application Details - K955684

Device Classification Name Injector And Syringe, Angiographic

  More FDA Info for this Device
510(K) Number K955684
Device Name Injector And Syringe, Angiographic
Applicant CONTOUR FABRICATORS OF FLORIDA, INC.
1247 FLORIDA AVE.
PALM HARBOR, FL 34683 US
Other 510(k) Applications for this Company
Contact PATRICK J LAMB
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 12/14/1995
Decision Date 05/02/1996
Decision SESK - SUBST EQUIV - KIT
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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