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

    SKIN SCRUB-TRAY

    K Number: K821579 · Decision Jul 21, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    59
    Applicant Total
    29
    Review Days
    54

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    Basic Information

    Device Name
    SKIN SCRUB-TRAY
    K Number
    K821579
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Associated Medical Products Co.
    Date Received
    May 28, 1982
    Decision Date
    July 21, 1982
    Product Code
    LDR
    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
    LDR Controller, Infusion, Intravascular, Electronic

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    K932218 CARDIAC CATH OR ANGIOGRAPHIC TRAYS
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