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

    REFLEX(R) ECA

    K Number: K924929 · Decision Jul 21, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    3
    Applicant Total
    8
    Review Days
    294

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    Basic Information

    Device Name
    REFLEX(R) ECA
    K Number
    K924929
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Richard-Allan Medical
    Date Received
    September 30, 1992
    Decision Date
    July 21, 1993
    Product Code
    HBT
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HBT Applier, Hemostatic Clip

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