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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K212846
Device Name Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use
Applicant
Jiangsu Jichun Medical Devices Co., Ltd.
NO.98, Baiyang Bridge, Zhenglu Town, Tianning
Changzhou,  CN 213111
Applicant Contact Zhu Pingnan
Correspondent
IRC
2950 E Lindrick Drive
Chandler,  AZ  85249
Correspondent Contact Charles Mack
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received09/07/2021
Decision Date 08/30/2022
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
Predetermined Change
Control Plan Authorized		 No
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