Child Face Mask

Pediatric/child Facemask

Shandong Shengquan New Material Co., Ltd.

The following data is part of a premarket notification filed by Shandong Shengquan New Material Co., Ltd. with the FDA for Child Face Mask.

Pre-market Notification Details

Device IDK201514
510k NumberK201514
Device Name:Child Face Mask
ClassificationPediatric/child Facemask
Applicant Shandong Shengquan New Material Co., Ltd. Diaozhen Industrial Development Zone, Zhangqiu District, Jinan,  CN 250204
ContactXiumei Zhang
CorrespondentShelley Li
Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705, Baohua International Plaza, West Guangzhong Road 555, Jingan Shanghai,  CN 200071
Product CodeOXZ  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-08
Decision Date2021-10-10

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