FDA 510(k) Application Details - K101839

Device Classification Name	More FDA Info for this Device
510(K) Number	K101839
Device Name	KANEKA PHARMA AMERICA XPRESS-WAY RX
Applicant	KANEKA PHARMA AMERICA LLC 5 WENTWORTH DRIVE HUDSON, NH 03051 US Other 510(k) Applications for this Company
Contact	RAYMOND KELLY Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2010
Decision Date	10/22/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review