Disposable Medical Masks

Mask, Surgical

Hantech Medical Device Co., Ltd.

The following data is part of a premarket notification filed by Hantech Medical Device Co., Ltd. with the FDA for Disposable Medical Masks.

Pre-market Notification Details

Device IDK221038
510k NumberK221038
Device Name:Disposable Medical Masks
ClassificationMask, Surgical
Applicant Hantech Medical Device Co., Ltd. No 288, Sanheng Road Changhe Industridal Park, Cixi Ningbo,  CN 315326
ContactArnold Yang
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2022-04-07
Decision Date2022-09-01

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