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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 K212207
Device Name Sterile Hypodermic Syringe for Single Use
Applicant
Shandong Weigao Group Medical Polymer Co., Ltd.
#18 Xingshan Rd., Torch Hi-Tech Science Park
Weihai,  CN 264210
Applicant Contact Lina Liu
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number880.5860
Classification Product Code
FMF  
Date Received07/15/2021
Decision Date 03/23/2023
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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