GENGIGEL MOUTHRINSE— 510(k) K053342

Substantially Equivalent

Ricerfarma Srl

FDA 510(k) clearance K053342 for GENGIGEL MOUTHRINSE, Substantially Equivalent on 2007-03-13. Applicant: Ricerfarma Srl.

Clearance details

Applicant: Ricerfarma Srl
Product code: Code OLR
Advisory panel: Unknown
Date received: 2005-12-01
Decision date: 2007-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Catonsville, MD, US

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Adverse events under product code OLR

product code OLR

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.