BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE

    K Number: K885171 · Decision Jan 12, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    83
    Applicant Total
    21
    Review Days
    30

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    Basic Information

    Device Name
    MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE
    K Number
    K885171
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5550
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Andover Medical, Inc.
    Date Received
    December 13, 1988
    Decision Date
    January 12, 1989
    Product Code
    DRO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

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