BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇦 Canada

    ALCOHOL PREP AND POVIDONE-IODINE PREP

    K Number: K896835 · Decision Jan 11, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    24
    Applicant Total
    2
    Review Days
    37

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    Basic Information

    Device Name
    ALCOHOL PREP AND POVIDONE-IODINE PREP
    K Number
    K896835
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Norpak Mfg., Inc.
    Date Received
    December 5, 1989
    Decision Date
    January 11, 1990
    Product Code
    LKB
    Advisory Committee
    Unknown
    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
    LKB Pad, Alcohol, Device Disinfectant

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    Other Clearances by Norpak Mfg., Inc.

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