FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE)

Separator, Automated, Blood Cell And Plasma, Therapeutic

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 Com.tec Automated Cell Separator, Model 9008031; Fresenius C5l, S5l, C5l-t Platelet Sets (5-day Storage).

Pre-market Notification Details

• Device ID: K060734
• 510k Number: K060734
• Device Name: FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE)
• Classification: Separator, Automated, Blood Cell And Plasma, Therapeutic
• Applicant: FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington, MA 02420
• Contact: Janet C Kay
• Correspondent: Janet C Kay; FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington, MA 02420
• Product Code: LKN
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2006-03-20
• Decision Date: 2006-09-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04086000901550	K060734	000
04086000860154	K060734	000