TIGER FLAT SURGICAL MASK— 510(k) K102713

Substantially Equivalent

Tiger Medical Products, Ltd.

FDA 510(k) clearance K102713 for TIGER FLAT SURGICAL MASK, Substantially Equivalent on 2011-01-25. Applicant: Tiger Medical Products, Ltd..

Clearance details

Applicant: Tiger Medical Products, Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2010-09-20
Decision date: 2011-01-25
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.