FDA 510(k) Application Details - K091315

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K091315
Device Name	Syringe, Piston
Applicant	CONFLUENT SURGICAL,INC 101A FIRST AVE. WALTHAM, MA 02451 US Other 510(k) Applications for this Company
Contact	SEAN REYNOLDS 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	05/04/2009
Decision Date	06/05/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review