ISOLATION MASKS— 510(k) K893939

Substantially Equivalent

James River Corp.

FDA 510(k) clearance K893939 for ISOLATION MASKS, Substantially Equivalent on 1989-07-14. Applicant: James River Corp..

Clearance details

Applicant: James River Corp.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1989-05-31
Decision date: 1989-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neenah, WI, 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.