FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK— 510(k) K122717

Substantially Equivalent

Tiger Medical Products, Ltd.

FDA 510(k) clearance K122717 for FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK, Substantially Equivalent on 2012-12-21. Applicant: Tiger Medical Products, Ltd..

Clearance details

Applicant: Tiger Medical Products, Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2012-09-05
Decision date: 2012-12-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Shanghai, CN

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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.