FDA.reportPublic FDA data

510(k) K214075

Device
Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)
Applicant
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
510(k) number
K214075
Product code
FMI
Decision
Substantially Equivalent (SESE)
Decision date
2022-04-12
Date received
2021-12-27
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
Bingyi Xiang
Address
#2 Guanyin Rd. Economic Development Zone Anqing CN 246400 246400

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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