Livocare Surgical Mask

Mask, Surgical

Andon Health Co., Ltd.

The following data is part of a premarket notification filed by Andon Health Co., Ltd. with the FDA for Livocare Surgical Mask.

Pre-market Notification Details

Device IDK201380
510k NumberK201380
Device Name:Livocare Surgical Mask
ClassificationMask, Surgical
Applicant Andon Health Co., Ltd. No. 3 Jin Ping Street,Ya An Road, Nankai District Tianjin,  CN 300190
ContactLiu Yi
CorrespondentLiu Yi
Andon Health Co., Ltd. No. 3 Jin Ping Street,Ya An Road, Nankai District Tianjin,  CN 300190
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-26
Decision Date2020-10-07

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