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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 K230061
Device Name Insulin 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
FMF  
Date Received01/09/2023
Decision Date 11/30/2023
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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