Medical Face Mask

Mask, Surgical

Chongqing Chaoke Industry Development Co., Ltd.

The following data is part of a premarket notification filed by Chongqing Chaoke Industry Development Co., Ltd. with the FDA for Medical Face Mask.

Pre-market Notification Details

Device IDK202714
510k NumberK202714
Device Name:Medical Face Mask
ClassificationMask, Surgical
Applicant Chongqing Chaoke Industry Development Co., Ltd. C31, Yangtze River Industry Park, Tea Garden New Zone, Nan'an District Chongqing,  CN 400067
ContactLiu Xincheng
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-16
Decision Date2021-06-11

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