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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K211555
Device Name Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe
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 Number880.5860
Classification Product Code
MEG  
Subsequent Product Codes
FMF   FMI  
Date Received05/19/2021
Decision Date 10/18/2021
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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