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