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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.
#2 Guanyin Rd., Taihu Economic Development Zone
Anqing,  CN 246400
Applicant Contact Bingyi Xiang
Correspondent
Shanghai Mind-Link Consulting Co., Ltd.
1399 Jiangyue Rd., 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
Predetermined Change
Control Plan Authorized		 No
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