FDA 510(k) Application Details - K102833

Device Classification Name	Catheter, Hemodialysis, Non-Implanted   More FDA Info for this Device
510(K) Number	K102833
Device Name	Catheter, Hemodialysis, Non-Implanted
Applicant	FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD P.O. BOX 237-023 SHANGHAI 200237 CN Other 510(k) Applications for this Company
Contact	Diana Hong Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	MPB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2010
Decision Date	11/18/2011
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