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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 K231729
Device Name Sterile syringes for single use with/without needle
Applicant
Wepon Medical Technology Co., Ltd.
Floor 4, Bldg. A, # 58, Jinhu Rd., Chengdong St.
Wenling,  CN 317500
Applicant Contact Di Zhao
Correspondent
Shanghai Lingfu Technology Co., Ltd.
4f # 585-2, Wanyuan Rd. Minhang District
Shanghai,  CN 201102
Correspondent Contact Esther Zhang
Regulation Number880.5570
Classification Product Code
FMI  
Date Received06/13/2023
Decision Date 09/08/2023
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
Predetermined Change
Control Plan Authorized		 No
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