TAIJI Professional Series Level 3 Surgical Face Mask— 510(k) K211861

Substantially Equivalent

Taiji Medical Supplies, Inc.

FDA 510(k) clearance K211861 for TAIJI Professional Series Level 3 Surgical Face Mask, Substantially Equivalent on 2021-07-28. Applicant: Taiji Medical Supplies, Inc..

Clearance details

Applicant
Taiji Medical Supplies, Inc.
Product code
Code FXX
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Lincolnton, 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.