FDA 510(k) Application Details - K963196

Device Classification Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days   More FDA Info for this Device
510(K) Number	K963196
Device Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant	VYGON CORP. ONE MADISON ST. EAST RUTHERFORD, NJ 07073 US Other 510(k) Applications for this Company
Contact	ANNE MARIE CESARIO Other 510(k) Applications for this Contact
Regulation Number	880.5200   More FDA Info for this Regulation Number
Classification Product Code	FOZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/1996
Decision Date	09/09/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review