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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, Bldg. B, Hai Ke Xing Tech Park, Baoshan Rd. #16,
Shenzhen,  CN 518118
Applicant Contact Jenny Lin
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
# 55 Shizhou Middle Rd., 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
Predetermined Change
Control Plan Authorized		 No
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