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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 K210216
Device Name Disposable Automatically Retractable Insulin Safety Syringe
Applicant
Shantou Wealy Medical Instrument Co.,Ltd
North Jinhuan Rd.
Shantou,  CN 515064
Applicant Contact Yuhe Yang
Correspondent
Shanghai Sungo Management Consulting Company Limited.
Rm. 1309, 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Raymond Luo
Regulation Number880.5860
Classification Product Code
MEG  
Subsequent Product Code
FMF  
Date Received01/27/2021
Decision Date 03/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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