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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 K221079
Device Name Sterile Hypodermic Syringes for Single Use
Applicant
Sichuan Prius Biotechnology Co., Ltd.
#2 Prius Rd., Luo Long Industrial Park Nanxi District
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 Number880.5860
Classification Product Code
FMF  
Date Received04/12/2022
Decision Date 10/04/2022
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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