EURO-COLLINS SOLUTION SETS

Set, Perfusion, Kidney, Disposable

FRESENIUS USA, INC.

The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Euro-collins Solution Sets.

Pre-market Notification Details

• Device ID: K884609
• 510k Number: K884609
• Device Name: EURO-COLLINS SOLUTION SETS
• Classification: Set, Perfusion, Kidney, Disposable
• Applicant: FRESENIUS USA, INC. VERWALTUNG: BORKENBERG 14 6370 OBERURSEL/TAUNUS 1 Germany, DE
• Contact: Eric Holst
• Correspondent: Eric Holst; FRESENIUS USA, INC. VERWALTUNG: BORKENBERG 14 6370 OBERURSEL/TAUNUS 1 Germany, DE
• Product Code: KDL
• CFR Regulation Number: 876.5880 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-11-07
• Decision Date: 1989-01-26