FDA 510(k) Application Details - K143497

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K143497
Device Name	Syringe, Antistick
Applicant	GUANGDONG INTMED MEDICAL APPLIANCE CO., LTD 1# SOUTH ROAD EUROPE INDUSTRY PARK, SHUNDE DISTRICT FOSHAN 528300 CN Other 510(k) Applications for this Company
Contact	HU YIHAN 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	12/09/2014
Decision Date	11/04/2015
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