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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 K220900
Device Name Safety Blood Collection Needles with/without Needle Holder
Applicant
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
#2 Guanyin Rd., Taihu Economic Development Zone,
Anqing City, Anhui Province
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 Number862.1675
Classification Product Code
JKA  
Date Received03/28/2022
Decision Date 08/10/2022
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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