Surgical Mask

Mask, Surgical

Allmed Medical Products Co., Ltd.

The following data is part of a premarket notification filed by Allmed Medical Products Co., Ltd. with the FDA for Surgical Mask.

Pre-market Notification Details

Device IDK202411
510k NumberK202411
Device Name:Surgical Mask
ClassificationMask, Surgical
Applicant Allmed Medical Products Co., Ltd. No. 99, Jin Shan Road, Majiadian Town Zhijiang,  CN
ContactVince Tian
CorrespondentIvy Wang
Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai,  CN 200122
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-21
Decision Date2021-03-10

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