FDA.report

510(k) K252886

Device
Pen Needle
Applicant
Hh Global Technology, Inc.
510(k) number
K252886
Product code
FMI
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-06
Date received
2025-09-10
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
N

Related Records

Applicant Contact

Contact
Grace Hammond
Address
6303 Woodlake Dr. Buford GA US 30518 30518

FDA Registration Numbers

Source Documents

510(k) summary PDF

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