Savewo ClassicMASK

Mask, Surgical

Savewo Limited

The following data is part of a premarket notification filed by Savewo Limited with the FDA for Savewo Classicmask.

Pre-market Notification Details

Device IDK221957
510k NumberK221957
Device Name:Savewo ClassicMASK
ClassificationMask, Surgical
Applicant Savewo Limited 1/F & 2/F, 266-270 Texaco Road, Tsuen Wan Hong Kong,  CN 0000
ContactMelanie Choi
CorrespondentIvy Lai
Long Jing Technology Ltd. 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong,  CN 0000
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-05
Decision Date2022-09-02

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