KNH Surgical Face Mask

Mask, Surgical

KNH Surgical Face Mask

The following data is part of a premarket notification filed by Knh Surgical Face Mask with the FDA for Knh Surgical Face Mask.

Pre-market Notification Details

Device IDK203528
510k NumberK203528
Device Name:KNH Surgical Face Mask
ClassificationMask, Surgical
Applicant KNH Surgical Face Mask 1, 2, 4F, Of No.66-1, Sanji, Jiangjun Village, Jiangjun District Tainan,  TW 72548
ContactRobert Y.L. Pan
CorrespondentBrian Wu
KNH Enterprise Co., Ltd 1, 2, 4F., No.66-1, Sanji, Jiangjun Village Jiangjun District Tainan City,  TW 725034
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-02
Decision Date2022-11-16

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