FDA 510(k) Application Details - K170095

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K170095
Device Name	Set, I.V. Fluid Transfer
Applicant	Medimop Medical Project Ltd. 17 Hatidhar St. Ra'anana 43665 IL Other 510(k) Applications for this Company
Contact	Ilanit Goldgraber 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	01/11/2017
Decision Date	03/08/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review