AMERICAN GOLD SERIES AUTOCLAVE— 510(k) K833837

Substantially Equivalent

Tuttnauer Co. , Ltd.

FDA 510(k) clearance K833837 for AMERICAN GOLD SERIES AUTOCLAVE, Substantially Equivalent on 1984-01-11. Applicant: Tuttnauer Co. , Ltd..

Clearance details

Applicant: Tuttnauer Co. , Ltd.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 1983-11-03
Decision date: 1984-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.