MASK, SURGICAL, DISPOSABLE— 510(k) K914412

Substantially Equivalent

Industries For the Blind

FDA 510(k) clearance K914412 for MASK, SURGICAL, DISPOSABLE, Substantially Equivalent on 1991-12-19. Applicant: Industries For the Blind.

Clearance details

Applicant: Industries For the Blind
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1991-10-01
Decision date: 1991-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greensboro, NC, 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.