Surgical Mask

Mask, Surgical

Tianchang Kanghui Protective Products CO LTD

The following data is part of a premarket notification filed by Tianchang Kanghui Protective Products Co Ltd with the FDA for Surgical Mask.

Pre-market Notification Details

Device IDK211255
510k NumberK211255
Device Name:Surgical Mask
ClassificationMask, Surgical
Applicant Tianchang Kanghui Protective Products CO LTD No.16 Wayeconomic Development Zone Tianchan,  CN 293900
ContactMark Wong
CorrespondentIvy Wang
Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai,  CN 200122
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-26
Decision Date2021-08-28

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