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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 K210761
Device Name Velguard Surgical Face Mask
Esstee Exports Health Care Division
8/3176 A3 & A4, Jothipuram, 2nd Street, Pandian Nagar,
PN Road
Tirupur,  IN 641602
Applicant Contact Zachary Wilson
Pathmaker FDA Law, PLLC
901 Twelve Oaks Center Drive
Wayzata,  MN  55391
Correspondent Contact Amy Fowler
Regulation Number878.4040
Classification Product Code
Date Received03/15/2021
Decision Date 07/16/2021
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