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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drills, Burrs, Trephines & Accessories (Compound, Powered)
510(k) Number K254177
Device Name Disposable Sterile Skull Drill (LZ)
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 Number882.4305
Classification Product Code
HBF  
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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