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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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