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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K232577
Device Name Radial Compression Device
Applicant
Ningbo Dizegens Medical Science Co.,Ltd
Floor 3&4, Bldg. A4, # 777, Binhai 4th Rd.
Qianwan New Area.
Ningo,  NJ  31533
Applicant Contact Zhang Wenwei
Correspondent
Ningbo Dizegens Medical Science Co.,Ltd
Floor 3&4, Bldg. A4, # 777, Binhai 4th Rd.
Qianwan New Area.
Ningo,  NJ  31533
Correspondent Contact Liqin Wang
Regulation Number870.4450
Classification Product Code
DXC  
Date Received08/25/2023
Decision Date 01/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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