GD Disposable Medical Face Mask

Mask, Surgical

Jiangsu Guangda Medical Material Group Co., Ltd.

The following data is part of a premarket notification filed by Jiangsu Guangda Medical Material Group Co., Ltd. with the FDA for Gd Disposable Medical Face Mask.

Pre-market Notification Details

Device IDK201718
510k NumberK201718
Device Name:GD Disposable Medical Face Mask
ClassificationMask, Surgical
Applicant Jiangsu Guangda Medical Material Group Co., Ltd. No. 18 Baochang Road (North) Libao Town,  CN
ContactGeorge Zhang
CorrespondentW. Victoria Rogers
Rogers Consulting 11110 Arranmore Cove Roanoke,  IN  46783
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-23
Decision Date2021-04-15

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