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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K223323
Device Name Blood Collection Needle (with/without Needle Holder)
Applicant
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
# 2 Guanyin Rd., Economic Development Zone, Taihu
Anqing City,  CN 246400
Applicant Contact Bingyi Xiang
Correspondent
Irc
2950 E Lindrick Dr.
Chandler,  AZ  85249
Correspondent Contact Charles Mack
Regulation Number862.1675
Classification Product Code
JKA  
Subsequent Product Code
FMI  
Date Received10/31/2022
Decision Date 03/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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