FDA.reportPublic FDA data

510(k) K221411

Device
Surflo Winged Infusion Set
Applicant
Terumo Medical Products (Hangzhou) Co., Ltd.
510(k) number
K221411
Product code
FPA
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-23
Date received
2022-05-16
Regulation
880.5440
Classification name
Set, Administration, Intravascular
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
Brian Byrd
Address
M4-9-5, Economic & Technological Development Zone Hangzhou CN 310018 310018

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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