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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 K213811
Device Name Sterile Hypodermic Syringes for Single Use
Applicant
Berpu Medical Technology Co., Ltd.
#14 Xingji Rd., Yongxing St.,
Wenzhou,  CN 325000
Applicant Contact Buxin Yu
Correspondent
Berpu Medical Technology Co., Ltd.
#14 Xingji Rd., Yongxing St.,
Wenzhou,  CN 325000
Correspondent Contact Buxin Yu
Regulation Number880.5860
Classification Product Code
FMF  
Date Received12/07/2021
Decision Date 05/12/2022
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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