FDA 510(k) Application Details - K960139

Device Classification Name	Instruments, Surgical, Cardiovascular   More FDA Info for this Device
510(K) Number	K960139
Device Name	Instruments, Surgical, Cardiovascular
Applicant	GE MEDICAL SYSTEMS 1247 FLORDIA AVE. PALM HARBOR, FL 34683 US Other 510(k) Applications for this Company
Contact	PATRICK J LAMB Other 510(k) Applications for this Contact
Regulation Number	870.4500   More FDA Info for this Regulation Number
Classification Product Code	DWS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/1996
Decision Date	04/19/1996
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review