FDA 510(k) Application Details - K183187

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K183187
Device Name	Set, I.V. Fluid Transfer
Applicant	SFM Medical Devices GmbH Brueckenstrasse 5 Waechtersbach Hessen 63607 DE Other 510(k) Applications for this Company
Contact	Olaf Br÷msen 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	11/19/2018
Decision Date	03/15/2019
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	Y
Expedited Review