FDA 510(k) Application Details - K192075

Device Classification Name	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System   More FDA Info for this Device
510(K) Number	K192075
Device Name	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Applicant	Epic Medical Pte. Ltd. 10 Jalan Besar, #06-04, Sim Lim Tower Singapore 208787 SG Other 510(k) Applications for this Company
Contact	Freddie Lee 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	08/02/2019
Decision Date	08/07/2020
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