ORAMOIST— 510(k) K122663

Substantially Equivalent

Quantum, Inc.

FDA 510(k) clearance K122663 for ORAMOIST, Substantially Equivalent on 2013-05-30. Applicant: Quantum, Inc..

Clearance details

Applicant: Quantum, Inc.
Product code: Code LFD
Advisory panel: Unknown
Date received: 2012-08-31
Decision date: 2013-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solon, OH, US

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Adverse events under product code LFD

product code LFD

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.