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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Scalp
510(k) Number K253814
Device Name Raney Clips Kit
Applicant
Beijing Honghugaoxiang Science and Technology Development CO
5 Bldg. W. Side, #3, Tiangui St., Zhongguancun Science
Park Daxing Biomedical Industry Base, Daxing District
Beijing,  CN 102600
Applicant Contact Zichen Jia
Correspondent
Beijing Honghugaoxiang Science and Technology Development CO
5 Bldg. W. Side, #3, Tiangui St., Zhongguancun Science
Park Daxing Biomedical Industry Base, Daxing District
Beijing,  CN 102600
Correspondent Contact Zichen Jia
Regulation Number882.4150
Classification Product Code
HBO  
Date Received11/28/2025
Decision Date 07/21/2026
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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