FDA 510(k) Application Details - K961763

Device Classification Name	More FDA Info for this Device
510(K) Number	K961763
Device Name	PULSE*SPRAY INFUSION SYSTEM
Applicant	ANGIODYNAMICS, DIV. E-Z-EM, INC. 603 QUEENSBURY AVE. QUEENSBURY, NY 12804 US Other 510(k) Applications for this Company
Contact	BRIAN KUNST Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/07/1996
Decision Date	07/17/1996
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