DeviceClearance

Trusana— 510(k) K230098

Substantially Equivalent

Myerson, LLC

FDA 510(k) clearance K230098 for Trusana, Substantially Equivalent on 2023-04-13. Applicant: Myerson, LLC. Device class: 2.

Clearance details

Applicant
Myerson, LLC
Product code
Code EBI
Device class
Class 2
Regulation
21 CFR 872.3760
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chicago, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code EBI

product code EBI
Other
1
Total
1

Source: openFDA MAUDE database, through . 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.