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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Drill, Electric
510(k) Number K254174
Device Name Surgical Power System
Applicant
Guizhou Zirui Technology Co., Ltd.
2f&3f, Bldg. B, Phase 1, Guizhou Loushanguan High-Tech
Industrial Development Zone, Chumi Town, Tongzi County
Zunyi,  CN 563200
Applicant Contact Chang Feng Liu
Correspondent
Nanos Medical Shanghai Limited
Rm. 1304, #88 Changning Rd.
Changning District
Shanghai,  CN 200042
Correspondent Contact Yoyo Chen
Regulation Number882.4360
Classification Product Code
HBC  
Subsequent Product Codes
EQJ   ERL   HBE   HBF   HWE  
Date Received12/23/2025
Decision Date 09/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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