FDA 510(k) Application Details - K162030

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K162030
Device Name	Syringe, Antistick
Applicant	SOL-MILLENNIUM MEDICAL, INC 1735 NORTH BROWN ROAD, SUITE 120 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	MEG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/22/2016
Decision Date	08/19/2016
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