FDA.reportPublic FDA data

510(k) K222271

Device
Verisafe Safety sterile needles
Applicant
Promisemed Hangzhou Meditech Co., Ltd.
510(k) number
K222271
Product code
FMI
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-15
Date received
2022-07-29
Regulation
880.5570
Classification name
Needle, Hypodermic, Single Lumen
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Zearou Yang
Address
# 1388 Cangxing St. Cangqian Community, Yuhang District Hangzhou City CN 311121 311121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FMI#

510(k), Device, Applicant table
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