3M SURGICAL MASK WITH FACE SHEILD— 510(k) K940707

Substantially Equivalent

3M Company

FDA 510(k) clearance K940707 for 3M SURGICAL MASK WITH FACE SHEILD, Substantially Equivalent on 1994-05-23. Applicant: 3M Company.

Clearance details

Applicant: 3M Company
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1994-02-17
Decision date: 1994-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, 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.