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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 K180259
Device Name Sterile Hypodermic Needle for Single Use
Applicant
Jiangsu Shenli Medical Production Co., Ltd.
No 20, Changzheng Rd., Zhenglu
Changzhou City,  CN 213111
Applicant Contact Tina Cai
Correspondent
Irc
2950 E Lindrick Dr.
Chandler,  AZ  85249
Correspondent Contact Charles Mack
Regulation Number880.5570
Classification Product Code
FMI  
Date Received01/30/2018
Decision Date 05/18/2018
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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