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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name syringe, piston
510(k) Number K234024
Device Name HWJECT Auto-disable syringe
Applicant
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd
No. 2 Guanyin Road, Taihu Economic Development Zone
Anqing,  CN 246400
Applicant Contact Bingyi Xiang
Correspondent
Shanghai Mind-Link Consulting Co., Ltd.
1399 Jiangyue Road, Minhang District
Shanghai,  CN 201114
Correspondent Contact Tanya Wang
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received12/20/2023
Decision Date 03/19/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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