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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K230043
Device Name Insulin Pen Needle
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 Business Consulting Co., Ltd.
Rm. 8208, Second Floor, No 1399, Jiangyue Rd.
Minhang District
Shanghai,  CN 201114
Correspondent Contact Alice Huang
Regulation Number880.5570
Classification Product Code
FMI  
Date Received01/06/2023
Decision Date 09/20/2023
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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