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

    CERVICAL COLLAR

    K Number: K780994 · Decision Jun 30, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    297
    Registration Numbers
    297
    Same Product Code
    26
    Applicant Total
    1
    Review Days
    16

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    Basic Information

    Device Name
    CERVICAL COLLAR
    K Number
    K780994
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3490
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Fox Instruments, Inc.
    Date Received
    June 14, 1978
    Decision Date
    June 30, 1978
    Product Code
    IQK
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IQK Orthosis, Cervical

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