Disposable Surgical Mask

Mask, Surgical

Xiamen Probtain Medical Techology Co., Ltd

The following data is part of a premarket notification filed by Xiamen Probtain Medical Techology Co., Ltd with the FDA for Disposable Surgical Mask.

Pre-market Notification Details

Device IDK202954
510k NumberK202954
Device Name:Disposable Surgical Mask
ClassificationMask, Surgical
Applicant Xiamen Probtain Medical Techology Co., Ltd 4th Floor, No.1 Building, No.6 Ji'an Road, Tong'an District Xiamen,  CN 361100
ContactJianli Kang
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)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-30
Decision Date2021-07-02

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