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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Reproductive
510(k) Number K242561
Device Name Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)
Applicant
Donnevie Medical Technology (Shanghai) Co. , Ltd.
Suite 201, Bld. 1, 138 Xinjun Ring
Minhang District
Shanghai,  CN 201114
Applicant Contact Hannah Hang Yin
Correspondent
Donnevie Medical Technology (Shanghai) Co. , Ltd.
Suite 201, Bld. 1, 138 Xinjun Ring
Minhang District
Shanghai,  CN 201114
Correspondent Contact Lily Liu
Regulation Number884.6180
Classification Product Code
MQL  
Date Received08/28/2024
Decision Date 04/10/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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