BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇮🇱 Israel

    PERIOPATCH

    K Number: K110750 · Decision Apr 28, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    34
    Applicant Total
    2
    Review Days
    42

    Basic Information

    Device Name
    PERIOPATCH
    K Number
    K110750
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MIS IMPLANTS TECHNOLOGIES LTD.
    Date Received
    March 17, 2011
    Decision Date
    April 28, 2011
    Product Code
    OLR
    Advisory Committee
    Unknown
    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
    OLR Oral Wound Dressing

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    Other Clearances by MIS IMPLANTS TECHNOLOGIES LTD.

    K Number Device Name
    K112162 CONICAL CONNECTION IMPLANTS