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FDA 510(k) Application Details - K221079
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K221079
Device Name
Syringe, Piston
Applicant
Sichuan Prius Biotechnology Co., Ltd.
No.2 Prius Road, Luo Long Industrial Park Nanxi District
Yibin 644104 CN
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Contact
Yan Liu
Other 510(k) Applications for this Contact
Regulation Number
880.5860
More FDA Info for this Regulation Number
Classification Product Code
FMF
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More FDA Info for this Product Code
Date Received
04/12/2022
Decision Date
10/04/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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