BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    PLPT LDV (Low Dead Volume) Sterile Syringe

    K Number: K210443 · Decision Feb 16, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    11
    Applicant Total
    6
    Review Days
    —

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    Basic Information

    Device Name
    PLPT LDV (Low Dead Volume) Sterile Syringe
    K Number
    K210443
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Poonglim Pharmatech, Inc.
    Date Received
    February 16, 2021
    Decision Date
    February 16, 2021
    Product Code
    QNQ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QNQ Low Dead Space Piston Syringe

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QNQ), ordered by most recent decision date.

    Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe

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    TSK Syringe

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    Small Volume 0.2mL Syringe

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    SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle

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    Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe

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    PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe

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    Other Clearances by Poonglim Pharmatech, Inc.

    K Number Device Name
    K241190 PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
    K221860 PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
    K210444 EZ-Injec LDV Sterile Safety Needle
    K192222 EZ-Inject Single use Needle
    K172483 Kopac Sterile Needle