ECOMA Level 2 Disposable Surgical Mask With Ear Loops

Mask, Surgical

Xianning Eco Medical Articles Co., Ltd.

The following data is part of a premarket notification filed by Xianning Eco Medical Articles Co., Ltd. with the FDA for Ecoma Level 2 Disposable Surgical Mask With Ear Loops.

Pre-market Notification Details

Device IDK210698
510k NumberK210698
Device Name:ECOMA Level 2 Disposable Surgical Mask With Ear Loops
ClassificationMask, Surgical
Applicant Xianning Eco Medical Articles Co., Ltd. No.16,Shutai Street High-Tech Industrial Zone Xianning,  CN 437000
ContactWei Zhou
CorrespondentWei Zhou
Xianning Eco Medical Articles Co., Ltd. No.16,Shutai Street High-Tech Industrial Zone Xianning,  CN 437000
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-08
Decision Date2021-08-19

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