FDA 510(k) Application Details - K102741

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K102741
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. P.O. BOX 237-023 SHANGHAI 200030 CN Other 510(k) Applications for this Company
Contact	Diana Hong Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/22/2010
Decision Date	11/08/2011
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