FDA 510(k) Application Details - K091760

Device Classification Name	Catheter, Hemodialysis, Implanted   More FDA Info for this Device
510(K) Number	K091760
Device Name	Catheter, Hemodialysis, Implanted
Applicant	DERMAPORT, INC 25102 RYE CANYON LOOP SUITE 110 SANTA CLARITA, CA 91355 US Other 510(k) Applications for this Company
Contact	JENNIFER HESSEL Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	MSD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/16/2009
Decision Date	07/20/2009
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