DUALGARD FACE SHIELD— 510(k) K934969

Substantially Equivalent

White Knight Healthcare

FDA 510(k) clearance K934969 for DUALGARD FACE SHIELD, Substantially Equivalent on 1994-03-28. Applicant: White Knight Healthcare.

Clearance details

Applicant: White Knight Healthcare
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1993-10-14
Decision date: 1994-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Childersburg, AL, 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.