FDA 510(k) Application Details - K100124

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K100124
Device Name	Needle, Hypodermic, Single Lumen
Applicant	PYNG MEDICAL CORP. 1351 CRESTWOOD PLACE UNIT 7 RICHMOND, BC V6V 2E9 CA Other 510(k) Applications for this Company
Contact	MAYA BUTTERFIELD 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	01/19/2010
Decision Date	08/31/2010
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	Y
Expedited Review