HEMO-NATE SYRINGE BLOOD FILTER— 510(k) K781815

Substantially Equivalent

Gisco Intl.

FDA 510(k) clearance K781815 for HEMO-NATE SYRINGE BLOOD FILTER, Substantially Equivalent on 1979-02-27. Applicant: Gisco Intl..

Clearance details

Applicant: Gisco Intl.
Product code: Code FPB
Advisory panel: General Hospital
Date received: 1978-10-24
Decision date: 1979-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code FPB

product code FPB

Other: 1
Total: 1

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.