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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 K233477
Device Name Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)
Applicant
Shandong Wego Ruisheng Medical Device Co., Ltd.
#1, Weigao Rd.
Torch High-Tech Industrial Development Zone
Weihai,  CN
Applicant Contact Yan Tian
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg.,
1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number884.6180
Classification Product Code
MQL  
Subsequent Product Code
MQK  
Date Received10/26/2023
Decision Date 07/01/2024
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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