Ideal Med Pro 3-Ply Disposable Face Mask— 510(k) K221682

Substantially Equivalent

Jsn Holdings, LLC

FDA 510(k) clearance K221682 for Ideal Med Pro 3-Ply Disposable Face Mask, Substantially Equivalent on 2023-01-13. Applicant: Jsn Holdings, LLC.

Clearance details

Applicant
Jsn Holdings, LLC
Product code
Code FXX
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Matthews, NC, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FXX

product code FXX
Injury
137
Total
137

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.