Procedure Mask, Surgical Mask

Mask, Surgical

Kenpax International Limited

The following data is part of a premarket notification filed by Kenpax International Limited with the FDA for Procedure Mask, Surgical Mask.

Pre-market Notification Details

Device IDK202899
510k NumberK202899
Device Name:Procedure Mask, Surgical Mask
ClassificationMask, Surgical
Applicant Kenpax International Limited Flat 5, 5/F, Wing On Plaza, 62 Mody Road Tsim Sha Tsui, Kowloon Hong Kong,  CN
ContactSolomon Chen
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-29
Decision Date2021-05-20

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