FDA 510(k) Application Details - K060190

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K060190
Device Name	Introducer, Catheter
Applicant	TOGO MEDIKIT CO., LTD. 5905 NATHAN LANE MAIL STOP P-25 PLYMOUTH, MN 55442 US Other 510(k) Applications for this Company
Contact	HEIDI M ERICKSON Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/24/2006
Decision Date	04/04/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review