FDA 510(k) Application Details - K142518

Device Classification Name Syringe, Piston

  More FDA Info for this Device
510(K) Number K142518
Device Name Syringe, Piston
Applicant ELI LILLY AND COMPANY
LILLY CORPORATE CENTER
INDIANAPOLIS, IN 46285 US
Other 510(k) Applications for this Company
Contact LeeAnn Chambers, MS., RAC
Other 510(k) Applications for this Contact
Regulation Number 880.5860

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

  More FDA Info for this Product Code
Date Received 09/08/2014
Decision Date 06/05/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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