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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 K230447
Device Name Sterile Syringe Bulk Tray
Applicant
Shanghai Kindly Enterprise Development Group Co., Ltd
No.658 Gaochao Road
Shanghai,  CN 201803
Applicant Contact Hualong Liu
Correspondent
Shanghai Mind-link Consulting Co., Ltd.
1399 Jiangyue Road, Minhang
Shanghai,  CN 201114
Correspondent Contact Evan Hu
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
MEG  
Date Received02/21/2023
Decision Date 08/16/2023
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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