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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 K221777
Device Name Disposable Sterile Syringe
Applicant
Weihai Shengjie Medical Technology Co., Ltd.
#58, Chuhe S. Rd.
High-Tech Industrial District, Weihai
Weihai,  CN 264210
Applicant Contact Huihui Wang
Correspondent
Weihai Shengjie Medical Technology Co., Ltd.
#58, Chuhe S. Rd.
High-Tech Industrial District, Weihai
Weihai,  CN 264210
Correspondent Contact Huihui Wang
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received06/21/2022
Decision Date 10/06/2023
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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