FDA 510(k) Application Details - K122787

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K122787
Device Name	Syringe, Piston
Applicant	SIMPLE DIAGNOSTICS, INC. 8870 RAVELLO CT NAPLES, FL 34114 US Other 510(k) Applications for this Company
Contact	DANIEL KAMM, P.E. 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	09/11/2012
Decision Date	12/06/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review