FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD— 510(k) K934974

Substantially Equivalent

Mid America Medical, Inc.

FDA 510(k) clearance K934974 for FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD, Substantially Equivalent on 1994-04-13. Applicant: Mid America Medical, Inc..

Clearance details

Applicant: Mid America Medical, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1993-10-19
Decision date: 1994-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Covington, KY, 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.