P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR— 510(k) K961706
Substantially EquivalentFresenius USA, Inc.
FDA 510(k) clearance K961706 for P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR, Substantially Equivalent on 1996-07-31. Applicant: Fresenius USA, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Fresenius USA, Inc.
- Product code
- Code LKN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walnut Creek, CA, US
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Adverse events under product code LKN
product code LKN- Death
- 50
- Injury
- 314
- Total
- 364
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.