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

    ONE STEP PREP KIT

    K Number: K811089 · Decision May 8, 1981
    View on FDA
    Classifications
    0
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    80
    Applicant Total
    10
    Review Days
    17

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    Basic Information

    Device Name
    ONE STEP PREP KIT
    K Number
    K811089
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Applicant
    Cunningham Woodland, Inc.
    Date Received
    April 21, 1981
    Decision Date
    May 8, 1981
    Product Code
    LDQ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

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