Medical Face Mask

Mask, Surgical

Shenzhen Lyttop Healthcare Limited

The following data is part of a premarket notification filed by Shenzhen Lyttop Healthcare Limited with the FDA for Medical Face Mask.

Pre-market Notification Details

Device IDK211353
510k NumberK211353
Device Name:Medical Face Mask
ClassificationMask, Surgical
Applicant Shenzhen Lyttop Healthcare Limited A201, Building 7, Dongjiu Innovation And Technology Park II, 73 Xiali South Road, Longgang District Shenzhen,  CN 518114
ContactLily Wu
CorrespondentIvy Wang
Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shangghai,  CN 200122
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-03
Decision Date2021-08-11

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