FDA.reportPublic FDA data

510(k) K232950

Device
Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle
Applicant
Perfect Medical Industry (Vn) Co., Ltd.
510(k) number
K232950
Product code
FMF
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-12
Date received
2023-09-20
Regulation
880.5860
Classification name
Syringe, Piston
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
Nancy Phan
Address
Block D/7i, # 1b Rd., Vinh Loc Industrial Zone Binh Hung Hoa B Ward, Bin Tan District Ho Chi Minh City VN 700000 700000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FMF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K251350BD Plastipak™ SyringeBecton, Dickinson and Company2025-07-29
K252033Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with NeedleCMT Health PTE., Ltd.2025-07-25
K2507333DOSE 1ml SyringeBimed Teknik Aletler Sanayi & Ticaret A.S.2025-07-03
K251648GPS Advanced; GPS Advanced CannulaProsidyan, Inc.2025-06-24
K250262GO-PEN®Go-Pen Aps2025-04-24