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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 K180073
Device Name Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set
Applicant
Shenzhen Vitavitro Bio-tech Co., Ltd
R601, Building B, Hai Ke Xing Tech Park
Baoshan Road No. 16
Shenzhen,  CN 518118
Applicant Contact Jenny Lin
Correspondent
Shenzhen Joyantech Consulting Co., Ltd
NO. 55 Shizhou middle road , Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Field Fu
Regulation Number884.6180
Classification Product Code
MQL  
Subsequent Product Code
MQK  
Date Received01/09/2018
Decision Date 08/29/2018
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
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