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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K221069
Device Name Infusion Sets for Single Use with Needles
Applicant
Sichuan Prius Biotechnology Co., Ltd.
#2 Prius Rd., Luo Long Industrial Park
Yibin,  CN 644104
Applicant Contact Yan Liu
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/12/2022
Decision Date 11/21/2022
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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