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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Low Dead Space Piston Syringe
510(k) Number K220083
Device Name LDV((Low Dead Volume )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
Shanghai,  CN 201114
Correspondent Contact Evan Hu
Regulation Number880.5860
Classification Product Code
QNQ  
Date Received01/10/2022
Decision Date 05/25/2022
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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