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

    MOERAE VEIN PREPARATION KIT

    K Number: K131659 · Decision Mar 3, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    76
    Applicant Total
    2
    Review Days
    270

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    Basic Information

    Device Name
    MOERAE VEIN PREPARATION KIT
    K Number
    K131659
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Moerae Matrix, Inc.
    Date Received
    June 6, 2013
    Decision Date
    March 3, 2014
    Product Code
    GBX
    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
    GBX Catheter, Irrigation

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    Other Clearances by Moerae Matrix, Inc.

    K Number Device Name
    DEN130004 MOERAE SURGICAL MARKING PEN