Dewin Reproductive Media (Dewin Fertilization Medium [with HSA And Without HSA] And Dewin Cleavage Medium [with HSA And Without HSA])

Media, Reproductive

DonneVie Medical Technology (Shanghai) Co. Ltd.

The following data is part of a premarket notification filed by Donnevie Medical Technology (shanghai) Co. Ltd. with the FDA for Dewin Reproductive Media (dewin Fertilization Medium [with Hsa And Without Hsa] And Dewin Cleavage Medium [with Hsa And Without Hsa]).

Pre-market Notification Details

Device IDK212426
510k NumberK212426
Device Name:Dewin Reproductive Media (Dewin Fertilization Medium [with HSA And Without HSA] And Dewin Cleavage Medium [with HSA And Without HSA])
ClassificationMedia, Reproductive
Applicant DonneVie Medical Technology (Shanghai) Co. Ltd. Suite 201, Bld 1, 138 Xinjun Ring Shanghai,  CN 201114
ContactHannah Hang Yin
CorrespondentStuart R. Goldman
Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin,  TX  78746
Product CodeMQL  
CFR Regulation Number884.6180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-04
Decision Date2022-06-16

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