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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 K214075
Device Name Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)
Applicant
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
No.2 Guanyin Road Economic Development Zone
Anqing,  CN 246400
Applicant Contact Bingyi Xiang
Correspondent
IRC
2950 E Lindrick Drive
Chandler,  AZ  85249
Correspondent Contact Charles Mack
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Code
FPA  
Date Received12/27/2021
Decision Date 04/12/2022
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
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