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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 K222452
Device Name Disposable Automatically Retractable Safety Syringes (with detachable needle)
Applicant
Shantou Wealy Medical Instrument Co.,Ltd
North Jinhuan Rd. (Near Of Qishan Mid-School)
Shantou,  CN 515064
Applicant Contact Yanjun Zhu
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number880.5860
Classification Product Code
MEG  
Subsequent Product Codes
FMF   FMI  
Date Received08/15/2022
Decision Date 11/23/2022
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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