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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 K221045
Device Name Insulin Syringes without needle
Applicant
Berpu Medical Technology Co., Ltd
No. 14 Xingji Road, Yongxing Street, Longwan District
Wenzhou,  CN 325000
Applicant Contact Buxin Yu
Correspondent
Berpu Medical Technology Co., Ltd
No. 14 Xingji Road, Yongxing Street, Longwan District
Wenzhou,  CN 325000
Correspondent Contact Buxin Yu
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/08/2022
Decision Date 11/03/2022
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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