AIC Disposable Medical Mask

Mask, Surgical

The Aleen International Corporation

The following data is part of a premarket notification filed by The Aleen International Corporation with the FDA for Aic Disposable Medical Mask.

Pre-market Notification Details

Device IDK203775
510k NumberK203775
Device Name:AIC Disposable Medical Mask
ClassificationMask, Surgical
Applicant The Aleen International Corporation Jiutian Green Science And Technology Industrial Park, Heyuan High-Tech Zone Heyuan,  CN 517000
ContactCan Huang
CorrespondentDiana Lam
Duocare, LLC 370 W. Grand Blvd, Suite 110 Corona,  CA  92882
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-28
Decision Date2021-03-12

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