Submission Details
| 510(k) Number | K895435 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 07, 1989 |
| Decision Date | November 02, 1990 |
| Days to Decision | 421 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
Cleared
Traditional
FRESENIUS AS 104 CELL SEPARATOR
Nov 1990
Decision
421d
Days
—
Risk
About This 510(k) Submission
K895435 is an FDA 510(k) clearance for the FRESENIUS AS 104 CELL SEPARATOR, a Separator, Automated, Blood Cell And Plasma, Therapeutic, submitted by Fresenius USA, Inc. (Concord, US). The FDA issued a Cleared decision on November 2, 1990, 421 days after receiving the submission on September 7, 1989. This device falls under the Gastroenterology & Urology review panel.
Device Classification
| Product Code | LKN — Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Device Class | — |
Manufacturer
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