MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573

Dialyzer, High Permeability With Or Without Sealed Dialysate System

FRESENIUS MEDICAL CARE NORTH AMERICA

The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Modification To:fresenius 2008t Hemodialysis Machine, Model 190573.

Pre-market Notification Details

• Device ID: K093902
• 510k Number: K093902
• Device Name: MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573
• Classification: Dialyzer, High Permeability With Or Without Sealed Dialysate System
• Applicant: FRESENIUS MEDICAL CARE NORTH AMERICA 920 Winter Street Waltham, MA 02451 -1457
• Contact: Randolph Quinn
• Correspondent: Randolph Quinn; FRESENIUS MEDICAL CARE NORTH AMERICA 920 Winter Street Waltham, MA 02451 -1457
• Product Code: KDI
• CFR Regulation Number: 876.5860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-12-22
• Decision Date: 2010-05-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840861100934	K093902	000
00840861100897	K093902	000