Silatrix Oral Gel— 510(k) K202000

Substantially Equivalent

Sa3, LLC

FDA 510(k) clearance K202000 for Silatrix Oral Gel, Substantially Equivalent on 2020-11-20. Applicant: Sa3, LLC.

Clearance details

Applicant: Sa3, LLC
Product code: Code OLR
Advisory panel: Unknown
Date received: 2020-07-20
Decision date: 2020-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, 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.