Surgical Face Mask

Mask, Surgical

Macheng Thimble Technology Investment Co., Ltd

The following data is part of a premarket notification filed by Macheng Thimble Technology Investment Co., Ltd with the FDA for Surgical Face Mask.

Pre-market Notification Details

Device IDK211631
510k NumberK211631
Device Name:Surgical Face Mask
ClassificationMask, Surgical
Applicant Macheng Thimble Technology Investment Co., Ltd Xiling 2nd Road, Douposhan Village, Macheng Economic Development Zone Huanggang,  CN 438000
ContactDonghong Sheng
CorrespondentIvy Wang
Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shangghai,  CN 200122
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-27
Decision Date2021-08-18

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