FDA 510(k) Applications Submitted by Megan Quevedo

FDA 510(k) Number Submission Date Device Name Applicant
K210321 02/04/2021 Dukal Corporation Level 1 Pediatric Face Mask Dukal Corporation
K201421 05/29/2020 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 Ons Dukal Corporation
K201732 06/25/2020 Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On Dukal Corporation
K212464 08/06/2021 Dukal Corporation AAMI Level 4 Open-Back Protective Gown Dukal Corporation
K203237 11/03/2020 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 Gown Dukal Corporation


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