Disposable Surgical Mask

Mask, Surgical

Shanghai Jianzhong Medical Packaging Co., Ltd.

The following data is part of a premarket notification filed by Shanghai Jianzhong Medical Packaging Co., Ltd. with the FDA for Disposable Surgical Mask.

Pre-market Notification Details

Device IDK202341
510k NumberK202341
Device Name:Disposable Surgical Mask
ClassificationMask, Surgical
Applicant Shanghai Jianzhong Medical Packaging Co., Ltd. Bldg. 16, 789# Puxing Rd, Minhang District Shanghai,  CN 201114
ContactNina Huang
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O.BOX 120-119 Shanghai,  CN 200120
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-17
Decision Date2021-02-12

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