FDA 510(k) Application Details - K132841

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K132841
Device Name	Set, Administration, Intravascular
Applicant	ZYNO MEDICAL LLC 177 PINE ST NATICK, MA 01760 US Other 510(k) Applications for this Company
Contact	MEI ZHANG, PHD Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/2013
Decision Date	01/23/2014
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