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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)
Shantou Wealy Medical Instrument CO.,Ltd.
North Jinhuan Road (near of Qishan mid-school)
Shantou,  CN 515064
Applicant Contact Yanjun Zhu
Shanghai SUNGO Management Consulting Co. Ltd.
Room 1401, Dongfang Building, 1500# Century Ave.,
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number880.5860
Classification Product Code
Subsequent Product Codes
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