WYZ Surgical Mask

Mask, Surgical

WYZ Medical Supplies LLC

The following data is part of a premarket notification filed by Wyz Medical Supplies Llc with the FDA for Wyz Surgical Mask.

Pre-market Notification Details

Device IDK211576
510k NumberK211576
Device Name:WYZ Surgical Mask
ClassificationMask, Surgical
Applicant WYZ Medical Supplies LLC 5913 Imperial Loop College Station,  TX  77845
ContactDaniel Chen
CorrespondentIvy Wang
Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai,  CN 200122
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-21
Decision Date2021-08-19

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