WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS)— 510(k) K001997

Substantially Equivalent

White Knight Healthcare, Inc.

FDA 510(k) clearance K001997 for WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS), Substantially Equivalent on 2001-04-02. Applicant: White Knight Healthcare, Inc..

Clearance details

Applicant: White Knight Healthcare, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2000-06-30
Decision date: 2001-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Port Riche, FL, US

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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.