JianYu Surgical Mask

Mask, Surgical

Jiangsu JianYu Health Medical Co., Ltd.

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

Pre-market Notification Details

Device IDK201754
510k NumberK201754
Device Name:JianYu Surgical Mask
ClassificationMask, Surgical
Applicant Jiangsu JianYu Health Medical Co., Ltd. No. 88 Longxi Avenue, Zhulin Town, Jintan District Changzhou,  CN 213241
ContactAndy Shu
CorrespondentAndy Shu
Jiangsu JianYu Health Medical Co., Ltd. No. 88 Longxi Avenue, Zhulin Town, Jintan District Changzhou,  CN 213241
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-29
Decision Date2020-12-30

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.