FDA 510(k) Application Details - K070234

Device Classification Name	Catheter, Hemodialysis, Non-Implanted   More FDA Info for this Device
510(K) Number	K070234
Device Name	Catheter, Hemodialysis, Non-Implanted
Applicant	JMS NORTH AMERICA CORP. 22320 FOOTHILL BLVD., SUITE 350 HAYWARD, CA 94541 US Other 510(k) Applications for this Company
Contact	SWEE CHEAU CHONG 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	01/16/2007
Decision Date	05/22/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review