FDA 510(k) Application Details - K080877

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K080877
Device Name	Syringe, Antistick
Applicant	UNILIFE MEDICAL SOLUTIONS LIMITED LEVEL 5, 35 CLARENCE STREET SYDNEY, NSW 2000 AU Other 510(k) Applications for this Company
Contact	MICHELLE GOW 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	03/31/2008
Decision Date	10/21/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review