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

    SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET

    K Number: K936226 · Decision Mar 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    231
    Registration Numbers
    231
    Same Product Code
    66
    Applicant Total
    53
    Review Days
    68

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    Basic Information

    Device Name
    SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET
    K Number
    K936226
    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
    Meadox Medicals, Div. Boston Scientific Corp.
    Date Received
    December 29, 1993
    Decision Date
    March 7, 1994
    Product Code
    KDC
    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
    KDC Instrument, Surgical, Disposable

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