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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 K212410
Device Name VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium
Applicant
Shenzhen VitaVitro Biotech Co.,Ltd.
R601, Building B, Hai Ke Xing Tech Park, Baoshan Road No.16
Shenzhen,  CN 518118
Applicant Contact Donghai Pan
Correspondent
Shenzhen VitaVitro Biotech Co.,Ltd.
R601, Building B, Hai Ke Xing Tech Park, Baoshan Road No.16
Shenzhen,  CN 518118
Correspondent Contact Donghai Pan
Regulation Number884.6180
Classification Product Code
MQL  
Date Received08/03/2021
Decision Date 02/01/2022
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
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