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

    HYPERALIMENTATION DRESSING TRAY

    K Number: K792369 · Decision Dec 10, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    24
    Review Days
    77

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    Basic Information

    Device Name
    HYPERALIMENTATION DRESSING TRAY
    K Number
    K792369
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Pharmaseal Div., Baxter Healthcare Corp.
    Date Received
    September 24, 1979
    Decision Date
    December 10, 1979
    Product Code
    FRG
    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
    FRG Wrap, Sterilization

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    K790409 LOW DEAD SPACE INSULIN SYRINGE
    K782069 TRAY, AUXILLARY BLOCK
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