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

    COOL CAST(R)

    K Number: K903946 · Decision Dec 31, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    30
    Applicant Total
    1
    Review Days
    126

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    Basic Information

    Device Name
    COOL CAST(R)
    K Number
    K903946
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.5940
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Hawthorne Products, Inc.
    Date Received
    August 27, 1990
    Decision Date
    December 31, 1990
    Product Code
    LGF
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LGF Component, Cast

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