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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 K242089
Device Name Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)
Applicant
Jiangsu Ruifuda Medical Device Co., Ltd.
1st Floor, # 567-12, Huaguoshan Ave.
Economic And Technological Development Area
Lianyungang,  CN 222022
Applicant Contact Jingkai Shao
Correspondent
Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
14f, Bldg. C, Ancillary Project Of Phase Iv Standard
Industrial Park, Guangzhou International Bio-Island
Guangdong,  CN 510320
Correspondent Contact Olivia Meng
Regulation Number884.6180
Classification Product Code
MQL  
Date Received07/17/2024
Decision Date 04/10/2025
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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