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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K201421
Device Name 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
Applicant
Dukal Corporation
2 Fleetwood Ct.
Ronkonkoma,  NY  11779
Applicant Contact Megan Quevedo
Correspondent
Dukal Corporation
2 Fleetwood Ct.
Ronkonkoma,  NY  11779
Correspondent Contact Megan Quevedo
Regulation Number878.4040
Classification Product Code
FXX  
Date Received05/29/2020
Decision Date 02/05/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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