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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 K254261
Device Name Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)
Applicant
CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.
Rm. 201 B2 Diamond Center, #66 Xixiaokou Rd.
Haidian District
Beijing,  CN 100192
Applicant Contact Kang Zhang
Correspondent
CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.
Rm. 201 B2 Diamond Center, #66 Xixiaokou Rd.
Haidian District
Beijing,  CN 100192
Correspondent Contact Kang Zhang
Regulation Number884.6180
Classification Product Code
MQL  
Date Received12/30/2025
Decision Date 08/28/2026
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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