FDA 510(k) Application Details - K130487

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K130487
Device Name	Needle, Hypodermic, Single Lumen
Applicant	PYNG MEDICAL CORP. 13480 CRESTWOOD PLACE UNIT 210 RICHMOND, BC V6V 2J9 CA Other 510(k) Applications for this Company
Contact	Michele Tyler 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	02/25/2013
Decision Date	06/25/2013
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