FDA 510(k) Application Details - K171131

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K171131
Device Name	Syringe, Piston
Applicant	Mazza Healthcare, LLC. 2101 Waukegan Road Suite 208 Bannockburn, IL 60015 US Other 510(k) Applications for this Company
Contact	Michael A. Mazza Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	FMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2017
Decision Date	11/08/2017
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