SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25— 510(k) K981693

Substantially Equivalent

Gebauer Co.

FDA 510(k) clearance K981693 for SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25, Substantially Equivalent on 2001-08-06. Applicant: Gebauer Co..

Clearance details

Applicant: Gebauer Co.
Product code: Code LFD
Advisory panel: Unknown
Date received: 1998-05-13
Decision date: 2001-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, 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.