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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 K220061
Device Name Safety Insulin Syringes
Applicant
Berpu Medical Technology Co., Ltd.
No. 14 Xingji Road, Yongxiing Street
Wenzhou,  CN 325000
Applicant Contact David Yu
Correspondent
Berpu Medical Technology Co., Ltd.
No. 14 Xingji Road, Yongxiing Street
Wenzhou,  CN 325000
Correspondent Contact David Yu
Regulation Number880.5860
Classification Product Code
MEG  
Subsequent Product Code
FMF  
Date Received01/10/2022
Decision Date 08/23/2022
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
Predetermined Change
Control Plan Authorized		 No
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