FDA 510(k) Application Details - K090162

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K090162
Device Name	Syringe, Piston
Applicant	OMRIX BIOPHARMACEUTICALS LTD. MDA BLOOD BANK SHEBA HOSPITAL, TEL HASHOMER RAMAT GAN 52621 IL Other 510(k) Applications for this Company
Contact	SARA HORN Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	FMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/22/2009
Decision Date	02/20/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review