MUGARD MUCOADHESIVE ORAL WOUND RINSE— 510(k) K062795

Substantially Equivalent

Access Pharmaceuticals, Inc.

FDA 510(k) clearance K062795 for MUGARD MUCOADHESIVE ORAL WOUND RINSE, Substantially Equivalent on 2006-12-11. Applicant: Access Pharmaceuticals, Inc..

Clearance details

Applicant: Access Pharmaceuticals, Inc.
Product code: Code OLR
Advisory panel: Unknown
Date received: 2006-09-18
Decision date: 2006-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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.