FDA 510(k) Application Details - K152597

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K152597
Device Name	Needle, Hypodermic, Single Lumen
Applicant	StarCap Medical LLC ( DBA Prism Medical & Design) 9604 Exbury Court Parkland, FL 33076 US Other 510(k) Applications for this Company
Contact	Les Capella Other 510(k) Applications for this Contact
Regulation Number	880.5570   More FDA Info for this Regulation Number
Classification Product Code	FMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/11/2015
Decision Date	06/08/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review