FDA 510(k) Application Details - K993518

Device Classification Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days   More FDA Info for this Device
510(K) Number	K993518
Device Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant	MEDEFIL, INC. 492 LUNT AVE. SCHAUMBURG, IL 60193 US Other 510(k) Applications for this Company
Contact	PRADEEP AGGARWAL 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	10/18/1999
Decision Date	06/12/2000
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