FDA 510(k) Application Details - K131646

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K131646
Device Name	Set, I.V. Fluid Transfer
Applicant	SHANGHAI JINTA MEDICAL CO., LTD NO. 18, JIANDING ROAD FENGJING TOWN, JINSHAN DISTRICT 201502 CN Other 510(k) Applications for this Company
Contact	WANG CHANGQING 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	06/05/2013
Decision Date	11/26/2013
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