BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇱 Israel

    SIALO DRAIN

    K Number: K072334 · Decision Jul 18, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    0
    Applicant Total
    4
    Review Days
    333

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    Basic Information

    Device Name
    SIALO DRAIN
    K Number
    K072334
    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
    Sialo Technology, Ltd.
    Date Received
    August 20, 2007
    Decision Date
    July 18, 2008
    Product Code
    OAJ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OAJ Catheter, Drainage, Intraoral/Extraoral

    Other Clearances by Sialo Technology, Ltd.

    K Number Device Name
    K093785 MODULAR ENDOSCOPE
    K082735 STONE GRASPING BASKET, MODEL PD-T1 2115
    K072749 SIALO BALLOON DILATATION CATHETER