LM Surgical Mask Level 3, LM Surgical Mask Level 2,

Mask, Surgical

Liberty Mask LLC

The following data is part of a premarket notification filed by Liberty Mask Llc with the FDA for Lm Surgical Mask Level 3, Lm Surgical Mask Level 2,.

Pre-market Notification Details

Device IDK211378
510k NumberK211378
Device Name:LM Surgical Mask Level 3, LM Surgical Mask Level 2,
ClassificationMask, Surgical
Applicant Liberty Mask LLC 1819 Firman Drive Suite 101 Richardson,  TX  75081
ContactWill Kincaid
CorrespondentTimothy Kania
mdi Consultants 55 Northern Blvd, Suite 200 Great Neck,  NY  11021
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-04
Decision Date2021-12-16

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