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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 K211751
Device Name WELLTRUST WT-III Mask with Flat Earloop
Applicant
Lonestar Meadows, LLC
8585 Commerce Park Dr., Suite 500
Houston,  TX  77036
Applicant Contact Karthik Sundaram
Correspondent
Regulatory Insight, Inc.
22 Golden Eagle Ln.
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/07/2021
Decision Date 09/17/2021
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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