DEFEND Ear-loop Face Masks

Mask, Surgical

Young Dental Manufacturing Co. 1, LLC

The following data is part of a premarket notification filed by Young Dental Manufacturing Co. 1, Llc with the FDA for Defend Ear-loop Face Masks.

Pre-market Notification Details

Device IDK201127
510k NumberK201127
Device Name:DEFEND Ear-loop Face Masks
ClassificationMask, Surgical
Applicant Young Dental Manufacturing Co. 1, LLC 13705 Shoreline Court East Earth City,  MO  63045
ContactJose Espino
CorrespondentJose Espino
Young Dental Manufacturing Co. 13705 Shoreline Ct. E. Earth City,  MO  63045
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-28
Decision Date2021-04-14

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