SAFE-T-FACE DISPOSABLE FACE SHIELD— 510(k) K892451

Substantially Equivalent

Barry S. Smith Co.

FDA 510(k) clearance K892451 for SAFE-T-FACE DISPOSABLE FACE SHIELD, Substantially Equivalent on 1989-05-15. Applicant: Barry S. Smith Co..

Clearance details

Applicant: Barry S. Smith Co.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1989-04-10
Decision date: 1989-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sacramento, CA, 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.