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

    RESTRAINTS (VESTS AND JACKETS)

    K Number: K971536 · Decision Jul 1, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    133
    Applicant Total
    2
    Review Days
    64

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    Basic Information

    Device Name
    RESTRAINTS (VESTS AND JACKETS)
    K Number
    K971536
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6760
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    E.M. Adams Co., Inc.
    Date Received
    April 28, 1997
    Decision Date
    July 1, 1997
    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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