P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR

Separator, Automated, Blood Cell And Plasma, Therapeutic

FRESENIUS USA, INC.

The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for P1r Plasma Treatment Set For Use In Plasmapheresis With The Fresenius As104 Cell Separator.

Pre-market Notification Details

• Device ID: K961706
• 510k Number: K961706
• Device Name: P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR
• Classification: Separator, Automated, Blood Cell And Plasma, Therapeutic
• 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: LKN
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-05-02
• Decision Date: 1996-07-31

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04052682003721	K961706	000