Surgical Face Mask— 510(k) K201545

Substantially Equivalent

Amphastar Nanjing Pharmaceuticals, Inc.

FDA 510(k) clearance K201545 for Surgical Face Mask, Substantially Equivalent on 2021-02-12. Applicant: Amphastar Nanjing Pharmaceuticals, Inc..

Clearance details

Applicant: Amphastar Nanjing Pharmaceuticals, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2020-06-09
Decision date: 2021-02-12
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Nanjing, 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.