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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Assisted Reproduction
510(k) Number K240523
Device Name VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
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 Number884.6100
Classification Product Code
MQE  
Date Received02/23/2024
Decision Date 11/15/2024
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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