FDA 510(k) Application Details - K032777

Device Classification Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days   More FDA Info for this Device
510(K) Number	K032777
Device Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant	NIPRO MEDICAL CORP. 510 STONEMONT DR. WESTON, FL 33326 US Other 510(k) Applications for this Company
Contact	RICHARD D BLISS 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	09/08/2003
Decision Date	11/14/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review