Standard Procedure Mask, Standard Surgical Mask

Mask, Surgical

Jiangsu Medplus Non-woven Manufacturer Co., Ltd.

The following data is part of a premarket notification filed by Jiangsu Medplus Non-woven Manufacturer Co., Ltd. with the FDA for Standard Procedure Mask, Standard Surgical Mask.

Pre-market Notification Details

Device IDK202605
510k NumberK202605
Device Name:Standard Procedure Mask, Standard Surgical Mask
ClassificationMask, Surgical
Applicant Jiangsu Medplus Non-woven Manufacturer Co., Ltd. No.217 East Wencheng Road, Economic Development Zone Siyang,  CN 223700
ContactShuying An
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 Received2020-09-08
Decision Date2021-02-10

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