FDA 510(k) Application Details - K180489

Device Classification Name	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System   More FDA Info for this Device
510(K) Number	K180489
Device Name	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Applicant	Teva Medical Ltd., Migada Plant North Industrial Zone Kiryat Shmona 10258 IL Other 510(k) Applications for this Company
Contact	Nadav Reuben Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	ONB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2018
Decision Date	09/21/2018
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