ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK— 510(k) K890771

Substantially Equivalent

3M Company

FDA 510(k) clearance K890771 for ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK, Substantially Equivalent on 1989-03-14. Applicant: 3M Company.

Clearance details

Applicant: 3M Company
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1989-02-14
Decision date: 1989-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cottae Grove, 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.