Disposable Face Mask

Mask, Surgical

Biobase Scientific (Shandong) Co., Ltd.

The following data is part of a premarket notification filed by Biobase Scientific (shandong) Co., Ltd. with the FDA for Disposable Face Mask.

Pre-market Notification Details

Device IDK210815
510k NumberK210815
Device Name:Disposable Face Mask
ClassificationMask, Surgical
Applicant Biobase Scientific (Shandong) Co., Ltd. No.1777 Dazheng Road, High-Tech District, Jinan City, Shandong Province, China Jinan,  CN 250000
ContactQingxiang Hou
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai,  CN 200120
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-18
Decision Date2021-05-13

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