FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290

Set, Tubing, Blood, With And Without Anti-regurgitation Valve

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 Fresenius Combillines Single Needle Blood Tubing Set, Catalog #03-2290.

Pre-market Notification Details

• Device ID: K000451
• 510k Number: K000451
• Device Name: FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290
• Classification: Set, Tubing, Blood, With And Without Anti-regurgitation Valve
• Applicant: FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington, MA 02173
• Contact: Arthur Eilinsfeld
• Correspondent: Arthur Eilinsfeld; FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington, MA 02173
• Product Code: FJK
• CFR Regulation Number: 876.5820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-02-11
• Decision Date: 2000-05-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10840861100283	K000451	000