FRESENIUS AS 104 CELL SEPARATOR— 510(k) K895435

Substantially Equivalent

Fresenius USA, Inc.

FDA 510(k) clearance K895435 for FRESENIUS AS 104 CELL SEPARATOR, Substantially Equivalent on 1990-11-02. Applicant: Fresenius USA, Inc..

Clearance details

Applicant: Fresenius USA, Inc.
Product code: Code LKN
Advisory panel: Unknown
Date received: 1989-09-07
Decision date: 1990-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, 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, 2020-01-01 through 2026-04-23. 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.