FDA 510(k) Application Details - K160870

Device Classification Name Set, Administration, Intravascular

  More FDA Info for this Device
510(K) Number K160870
Device Name Set, Administration, Intravascular
Applicant HOSPIRA, INC.
375 FIELD DRIVE
LAKE FOREST, IL 60045 US
Other 510(k) Applications for this Company
Contact DAVID BLONSKI
Other 510(k) Applications for this Contact
Regulation Number 880.5440

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

  More FDA Info for this Product Code
Date Received 03/30/2016
Decision Date 06/01/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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