FDA 510(k) Application Details - K050116

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K050116
Device Name	Syringe, Antistick
Applicant	UNIQSAFE BIOMEDITECH CO., LTD. 3892 SOUTH AMERICA WEST TRAIL FLAGSTAFF, AZ 86001 US Other 510(k) Applications for this Company
Contact	JENNIFER REICH 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	01/18/2005
Decision Date	05/09/2005
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