Surgical Mask

Mask, Surgical

Ningbo Jingeao Electronics Inc.

The following data is part of a premarket notification filed by Ningbo Jingeao Electronics Inc. with the FDA for Surgical Mask.

Pre-market Notification Details

Device IDK202746
510k NumberK202746
Device Name:Surgical Mask
ClassificationMask, Surgical
Applicant Ningbo Jingeao Electronics Inc. No.2 Jinyuan Road, Longshan Industrial Zone Cixi,  CN 315311
ContactYiyun Yu
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. Room 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 Received2020-09-18
Decision Date2021-08-27

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