FDA 510(k) Application Details - K173577

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K173577
Device Name	Set, I.V. Fluid Transfer
Applicant	International Medical Industries Inc. 2981 Gateway Drive Pompano Beach, FL 33069 US Other 510(k) Applications for this Company
Contact	Brandon Hunt 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	11/20/2017
Decision Date	06/07/2018
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