BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE

    K Number: K082689 · Decision Mar 20, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    39
    Applicant Total
    6
    Review Days
    186

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    Basic Information

    Device Name
    STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
    K Number
    K082689
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spectra Medical Devices, Inc.
    Date Received
    September 15, 2008
    Decision Date
    March 20, 2009
    Product Code
    NGT
    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
    NGT Saline, Vascular Access Flush

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    Other Clearances by Spectra Medical Devices, Inc.

    K Number Device Name
    K151069 SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
    K103740 SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE
    K082580 SPECTRA GUIDEWIRE INTRODUCER NEEDLE
    K082674 SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE
    K081524 SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L