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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 K212426
Device Name Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])
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
Emergo Global Consulting, LLC
2500 Bee Cave Rd., Bldg. 1 Suite 300
Austin,  TX  78746
Correspondent Contact Stuart R. Goldman
Regulation Number884.6180
Classification Product Code
MQL  
Date Received08/04/2021
Decision Date 06/16/2022
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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