FDA 510(k) Application Details - K121476

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K121476
Device Name	Syringe, Piston
Applicant	PINNACLE SPINE GROUP, LLC 1601 Elm St Ste 1930 Dallas, TX 75201 US Other 510(k) Applications for this Company
Contact	Rebecca K Pine 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	05/18/2012
Decision Date	08/29/2012
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