Disposable Medical Face Mask

Mask, Surgical

Suzhou Bolisi Medical Technology Co., Ltd

The following data is part of a premarket notification filed by Suzhou Bolisi Medical Technology Co., Ltd with the FDA for Disposable Medical Face Mask.

Pre-market Notification Details

Device IDK210244
510k NumberK210244
Device Name:Disposable Medical Face Mask
ClassificationMask, Surgical
Applicant Suzhou Bolisi Medical Technology Co., Ltd Baijiaqiao Industrial Community, Yangshe Town Zhangjiagang,  CN 215000
ContactHong Xu
CorrespondentRyan Li
Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shanghai,  CN 200040
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-29
Decision Date2021-07-12

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