DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560— 510(k) K061864

Substantially Equivalent

Dukal Corp.

FDA 510(k) clearance K061864 for DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560, Substantially Equivalent on 2006-09-15. Applicant: Dukal Corp..

Clearance details

Applicant: Dukal Corp.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2006-07-03
Decision date: 2006-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, 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.