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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Assisted Reproduction
510(k) Number K240307
Device Name VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)
Applicant
Shenzhen Vitavitro Biotech Co., Ltd.
R601, Bldg. B, Hai Ke Xing Tech Park, Baoshan Rd. #16,
Shenzhen,  CN 518118
Applicant Contact Donghai Pan
Correspondent
Shenzhen Vitavitro Biotech Co., Ltd.
R601, Bldg. B, Hai Ke Xing Tech Park, Baoshan Rd. #16,
Shenzhen,  CN 518118
Correspondent Contact Donghai Pan
Regulation Number884.6110
Classification Product Code
MQF  
Date Received02/02/2024
Decision Date 08/16/2024
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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