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Dukal Corporation

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories4
Latest FDA decision2022-03-30
TypeNumberDevice NameCodeDateActions
510(k) K212464 Dukal Corporation AAMI Level 4 Open-Back Protective GownQPC2022-03-30 View
510(k) K210321 Dukal Corporation Level 1 Pediatric Face MaskOXZ2022-03-29 View
510(k) K203237 Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical GownFYA2022-03-18 View
510(k) K201732 Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie OnFXX2021-02-16 View
510(k) K201421 Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie OnsFXX2021-02-05 View
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