Disposable Surgical Mask

Mask, Surgical

Suzhou Letian Protective Products Co., Ltd.

The following data is part of a premarket notification filed by Suzhou Letian Protective Products Co., Ltd. with the FDA for Disposable Surgical Mask.

Pre-market Notification Details

Device IDK210042
510k NumberK210042
Device Name:Disposable Surgical Mask
ClassificationMask, Surgical
Applicant Suzhou Letian Protective Products Co., Ltd. No. 12 Zhenfeng Road, Nanfeng Town Suzhou,  CN 215600
ContactHuang Qizhi
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-07
Decision Date2021-11-17

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