FDA 510(k) Application Details - K150219

Device Classification Name	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System   More FDA Info for this Device
510(K) Number	K150219
Device Name	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Applicant	EQUASHIELD MEDICAL LTD TEFEN INDUSTRIAL PARK P.O. B 12 MIGDAL 24959 IL Other 510(k) Applications for this Company
Contact	Raymond J Kelly 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	01/30/2015
Decision Date	11/05/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review