Disposable Surgical Mask

Mask, Surgical

Xiamen Eagledon Pharmaceutical Co., Ltd

The following data is part of a premarket notification filed by Xiamen Eagledon Pharmaceutical Co., Ltd with the FDA for Disposable Surgical Mask.

Pre-market Notification Details

Device IDK210267
510k NumberK210267
Device Name:Disposable Surgical Mask
ClassificationMask, Surgical
Applicant Xiamen Eagledon Pharmaceutical Co., Ltd No.220-228, Meihe 3rd Road Xiamen,  CN 361100
ContactAggie Zhang
CorrespondentRuth Wu
Kavalan Consulting Inc. 1100 First Ave. Ste 305 King Of Prussia,  PA  19406
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-01
Decision Date2021-07-08

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