FDA 510(k) Application Details - K092938

Device Classification Name	Heparin, Vascular Access Flush   More FDA Info for this Device
510(K) Number	K092938
Device Name	Heparin, Vascular Access Flush
Applicant	APP PHARMACEUTICALS, LLC 962 ALLEGRO LN. APOLLO BEACH, FL 33572 US Other 510(k) Applications for this Company
Contact	ARTHUR WARD Other 510(k) Applications for this Contact
Regulation Number	880.5200   More FDA Info for this Regulation Number
Classification Product Code	NZW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2009
Decision Date	06/18/2010
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