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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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