Surgical Mask-Model Number CW01— 510(k) K202354

Substantially Equivalent

Hunan Heng Chang Pharmaceutical Co., Ltd.

FDA 510(k) clearance K202354 for Surgical Mask-Model Number CW01, Substantially Equivalent on 2020-09-08. Applicant: Hunan Heng Chang Pharmaceutical Co., Ltd..

Clearance details

Applicant: Hunan Heng Chang Pharmaceutical Co., Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2020-08-19
Decision date: 2020-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changsha, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

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.