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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 K234023
Device Name Oocyte Flushing & Retrieval Medium; Gamete Buffer
Applicant
Gimbo Medical Technology Shenzhen Co., Ltd.
601, Bldg. C5, # 459 Qiaokai Rd., Fenghuang St.
Guangming District
Shezhen,  CN 518107
Applicant Contact Leo Guo
Correspondent
Gimbo Medical Technology Shenzhen Co., Ltd.
601, Bldg. C5, # 459 Qiaokai Rd., Fenghuang St.
Guangming District
Shezhen,  CN 518107
Correspondent Contact Leo Guo
Regulation Number884.6180
Classification Product Code
MQL  
Date Received12/20/2023
Decision Date 05/10/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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