FDA 510(k) Application Details - K101309

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K101309
Device Name	Set, I.V. Fluid Transfer
Applicant	EXELINT INTERNATIONAL CO. 5840 W. CENTINELA AVE. LOS ANGELES, CA 90045 US Other 510(k) Applications for this Company
Contact	ARMAND HAMID Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	LHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/10/2010
Decision Date	10/20/2010
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