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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 K210772
Device Name 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)
Applicant
Vr Vertical, LLC Dba Xrgo
10645 Freeport Dr.
Louisville,  KY  40258
Applicant Contact Matthew DiPalma
Correspondent
Vr Vertical Dba Xrgo
10645 Freeport Dr.
Louisville,  KY  40258
Correspondent Contact Nathaniel Victor
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/15/2021
Decision Date 09/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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