NON-STERILE SURGICAL MASK— 510(k) K051291

Substantially Equivalent

A.R. Medicom, Inc.

FDA 510(k) clearance K051291 for NON-STERILE SURGICAL MASK, Substantially Equivalent on 2005-09-20. Applicant: A.R. Medicom, Inc..

Clearance details

Applicant: A.R. Medicom, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2005-05-18
Decision date: 2005-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lachine (Montreal), CA

Download summary PDF View on FDA.gov ↗

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.