SURGICAL MASK (NON-STERILE)— 510(k) K955513

Substantially Equivalent

United Medical Ent., Inc.

FDA 510(k) clearance K955513 for SURGICAL MASK (NON-STERILE), Substantially Equivalent on 1996-04-22. Applicant: United Medical Ent., Inc..

Clearance details

Applicant: United Medical Ent., Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1995-12-04
Decision date: 1996-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grovetown, GA, 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.