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

    CENTURION PROTECTIVE RESTRAINT, SCR SERIES

    K Number: K080448 · Decision Aug 28, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    133
    Applicant Total
    16
    Review Days
    191

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    Basic Information

    Device Name
    CENTURION PROTECTIVE RESTRAINT, SCR SERIES
    K Number
    K080448
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6760
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tri-State Hospital Supply Corp.
    Date Received
    February 19, 2008
    Decision Date
    August 28, 2008
    Product Code
    FMQ
    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
    FMQ Restraint, Protective

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