BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PAD, PRE-OPERATIVE PREPARATION

    K Number: K850811 · Decision Mar 21, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    573
    Registration Numbers
    573
    Same Product Code
    64
    Applicant Total
    7
    Review Days
    21

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    Basic Information

    Device Name
    PAD, PRE-OPERATIVE PREPARATION
    K Number
    K850811
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6060
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    East Texas Lighthouse For the Blind
    Date Received
    February 28, 1985
    Decision Date
    March 21, 1985
    Product Code
    KME
    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
    KME Bedding, Disposable, Medical

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