FDA.report

510(k) K221073

Device
Sterile Hypodermic Syringes for Single Use with Safety Needles
Applicant
Sichuan Prius Biotechnology Co., Ltd.
510(k) number
K221073
Product code
MEG
Decision
Substantially Equivalent (SESE)
Decision date
2022-10-04
Date received
2022-04-12
Regulation
880.5860
Classification name
Syringe, Antistick
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Yan Liu
Address
#2 Prius Rd., Luo Long Industrial Park Nanxi District Yibin CN 644104 644104

FDA Registration Numbers

Source Documents

510(k) summary PDF

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