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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Assisted Reproduction
510(k) Number K260194
Device Name Vacuum Pump (Model: AD-VPUM-500)
Applicant
Sheng Sheng Yi (Beijing) Technology Company Limited
Rm.235-238, Jianjin Ctr, # Jia 1, Yongtaiyuan, Qinghe
Haidian Dist, Rm.201, Bldg. 4, # 25 Yanqi 4th S St., Huairou
Beijing,  CN 100085
Applicant Contact Lili Wang
Correspondent
Sheng Sheng Yi (Beijing) Technology Company Limited
Rm.235-238, Jianjin Ctr, # Jia 1, Yongtaiyuan, Qinghe
Haidian Dist, Rm.201, Bldg. 4, # 25 Yanqi 4th S St., Huairou
Beijing,  CN 100085
Correspondent Contact Wei Zhao
Regulation Number884.6120
Classification Product Code
MQG  
Date Received01/22/2026
Decision Date 04/28/2026
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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