FDA 510(k) Application Details - K093546

Device Classification Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days   More FDA Info for this Device
510(K) Number	K093546
Device Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant	TOGO MEDIKIT CO., LTD. 4-1-17 HONGO, BUNKYO-KU TOKYO 113-0033 JP Other 510(k) Applications for this Company
Contact	FUMIAKI KANAI, PH.D 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	11/17/2009
Decision Date	12/17/2009
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