P1R Plasma Treatment Set for Use in Plasmapheresis with the Fresenius AS104 Cell Separator
FDA 510(k) K961706 · Fresenius USA, Inc.
510(k) numberK961706
Submission
- Device name
- P1R Plasma Treatment Set for Use in Plasmapheresis with the Fresenius AS104 Cell Separator
- Applicant
- Fresenius USA, Inc.
Walnut Creek, CA, US - Received
- May 2, 1996
- Decision date
- July 31, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LKN – Separator, Automated, Blood Cell And Plasma, Therapeutic
- Device class
- Unclassified
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Questions and answers
When was P1R Plasma Treatment Set for Use in Plasmapheresis with the Fresenius AS104 Cell Separator cleared by the FDA?
P1R Plasma Treatment Set for Use in Plasmapheresis with the Fresenius AS104 Cell Separator (K961706) received a 510(k) decision of Substantially Equivalent on July 31, 1996, 90 days after the submission was received.
What is the product code of K961706?
The FDA product code is LKN – Separator, Automated, Blood Cell And Plasma, Therapeutic, a Unclassified device.