WELLTRUST WT-III Mask With Flat Earloop

Mask, Surgical

Lonestar Meadows LLC

The following data is part of a premarket notification filed by Lonestar Meadows Llc with the FDA for Welltrust Wt-iii Mask With Flat Earloop.

Pre-market Notification Details

Device IDK211751
510k NumberK211751
Device Name:WELLTRUST WT-III Mask With Flat Earloop
ClassificationMask, Surgical
Applicant Lonestar Meadows LLC 8585 Commerce Park Dr., Suite 500 Houston,  TX  77036
ContactKarthik Sundaram
CorrespondentKevin Walls
Regulatory Insight, Inc. 22 Golden Eagle Lane Littleton,  CO  80127
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-07
Decision Date2021-09-17

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