FDA 510(k) Application Details - K082674

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K082674
Device Name	Syringe, Piston
Applicant	SPECTRA MEDICAL DEVICES, INC. 260-F FORDHAM RD WILMINGTON, MA 01887 US Other 510(k) Applications for this Company
Contact	SCOTT HENDERSON 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	09/15/2008
Decision Date	11/28/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review