MEBO Wound Dressing

Dressing, Wound, Drug

MEBO Life Science Inc.

The following data is part of a premarket notification filed by Mebo Life Science Inc. with the FDA for Mebo Wound Dressing.

Pre-market Notification Details

Device IDK193439
510k NumberK193439
Device Name:MEBO Wound Dressing
ClassificationDressing, Wound, Drug
Applicant MEBO Life Science Inc. 325 North Puente Street # A Brea,  CA  92821
ContactSidney Hong
CorrespondentWei Shan Hsu
Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong,  CN
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2019-12-11
Decision Date2020-09-04

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