SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP— 510(k) K063043

Substantially Equivalent

Modern Healthcare Corp.

FDA 510(k) clearance K063043 for SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP, Substantially Equivalent on 2007-03-21. Applicant: Modern Healthcare Corp..

Clearance details

Applicant: Modern Healthcare Corp.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2006-10-03
Decision date: 2007-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin-Chu City, TW

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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.