K060734 is an FDA 510(k) clearance for the FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031. This device is classified as a Separator, Automated, Blood Cell And Plasma, Therapeutic.
Submitted by Fresenius Medical Care North America (Lexington, US). The FDA issued a Cleared decision on September 5, 2006, 169 days after receiving the submission on March 20, 2006.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K060734 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2006 |
| Decision Date | September 05, 2006 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LKN — Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Device Class | — |