FDA 510(k) Application Details - K153537

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K153537
Device Name	Syringe, Piston
Applicant	SOL-MILLENNIUM MEDICAL, INC. 1735 North Brown Road, Suite 100 Lawrenceville, GA 30043 US Other 510(k) Applications for this Company
Contact	Jim Barley 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	12/10/2015
Decision Date	06/17/2016
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