Single-use Medical Face Mask— 510(k) K203591

Substantially Equivalent

Conod Medical Co., Limited

FDA 510(k) clearance K203591 for Single-use Medical Face Mask, Substantially Equivalent on 2021-07-02. Applicant: Conod Medical Co., Limited.

Clearance details

Applicant
Conod Medical Co., Limited
Product code
Code FXX
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Changshu, CN
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.