Submission Details
| 510(k) Number | K961706 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 02, 1996 |
| Decision Date | July 31, 1996 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
Cleared
Traditional
P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR
Jul 1996
Decision
90d
Days
—
Risk
About This 510(k) Submission
K961706 is an FDA 510(k) clearance for the P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR, a Separator, Automated, Blood Cell And Plasma, Therapeutic, submitted by Fresenius USA, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on July 31, 1996, 90 days after receiving the submission on May 2, 1996. 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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