FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX

Hemodialyzer, Re-use, Low Flux

FRESENIUS USA, INC.

The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Fresenius Polysulfone Hemodialyzers, Both Low And High Flux.

Pre-market Notification Details

• Device ID: K970700
• 510k Number: K970700
• Device Name: FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
• Classification: Hemodialyzer, Re-use, Low Flux
• Applicant: FRESENIUS USA, INC. 2637 SHADELANDS DR. Walnut Creek, CA 94598
• Contact: Tom Folden
• Correspondent: Tom Folden; FRESENIUS USA, INC. 2637 SHADELANDS DR. Walnut Creek, CA 94598
• Product Code: MSE
• CFR Regulation Number: 876.5820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-02-25
• Decision Date: 1998-09-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10840861100061	K970700	000
10840861100054	K970700	000