DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE— 510(k) K070407

Substantially Equivalent

Dukal Corp.

FDA 510(k) clearance K070407 for DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE, Substantially Equivalent on 2007-03-26. Applicant: Dukal Corp..

Clearance details

Applicant: Dukal Corp.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2007-02-12
Decision date: 2007-03-26
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.