3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95— 510(k) K955382

Substantially Equivalent

3M Company

FDA 510(k) clearance K955382 for 3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95, Substantially Equivalent on 1996-05-01. Applicant: 3M Company.

Clearance details

Applicant: 3M Company
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1995-11-24
Decision date: 1996-05-01
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.