CPS-1000— 510(k) K802890

Substantially Equivalent

Gics Pharmaceuticals

FDA 510(k) clearance K802890 for CPS-1000, Substantially Equivalent on 1981-03-05. Applicant: Gics Pharmaceuticals.

Clearance details

Applicant: Gics Pharmaceuticals
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 1980-11-17
Decision date: 1981-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.