3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks With Ties (XMM3HT)

Mask, Surgical

VR Vertical LLC Dba XRGO

The following data is part of a premarket notification filed by Vr Vertical Llc Dba Xrgo with the FDA for 3-layer Medical Face Masks (xmm3l3c), 3-layer Medical Face Masks With Ties (xmm3ht).

Pre-market Notification Details

Device IDK210772
510k NumberK210772
Device Name:3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks With Ties (XMM3HT)
ClassificationMask, Surgical
Applicant VR Vertical LLC Dba XRGO 10645 Freeport Drive Louisville,  KY  40258
ContactMatthew Dipalma
CorrespondentNathaniel Victor
VR Vertical Dba XRGO 10645 Freeport Drive Louisville,  KY  40258
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-15
Decision Date2021-09-22

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