FDA 510(k) Application Details - K052267

Device Classification Name	Needle, Fistula   More FDA Info for this Device
510(K) Number	K052267
Device Name	Needle, Fistula
Applicant	TOGO MEDIKIT CO., LTD. 4-2-1 YUSHIMA BUNKYO-KU TOKYO 113-0034 JP Other 510(k) Applications for this Company
Contact	FUMIAKI KANAI Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	FIE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/19/2005
Decision Date	10/27/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review