MASK, SURGICAL-DISPOSABLE NSN 6510-00-982-7493— 510(k) K903486

Substantially Equivalent

Pennsylvania Association For the Blind

FDA 510(k) clearance K903486 for MASK, SURGICAL-DISPOSABLE NSN 6510-00-982-7493, Substantially Equivalent on 1990-10-23. Applicant: Pennsylvania Association For the Blind.

Clearance details

Applicant: Pennsylvania Association For the Blind
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1990-07-31
Decision date: 1990-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, PA, 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.