MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098— 510(k) K062653

Name: FDA 510(k) clearance K062653
Creator: U.S. Food and Drug Administration
Published: 2006-10-27

Substantially Equivalent

Parnell Pharmaceuticals, Inc.

FDA 510(k) clearance K062653 for MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098, Substantially Equivalent on 2006-10-27. Applicant: Parnell Pharmaceuticals, Inc.. Device class: Unclassified.

Clearance details

Applicant: Parnell Pharmaceuticals, Inc.
Product code: Code LFD
Device class: Unclassified
Advisory panel: Unknown
Date received: 2006-09-07
Decision date: 2006-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Rafael, CA, US

Download summary PDF View on FDA.gov ↗

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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.