BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇮🇪 Ireland

    COLLACARE DENTAL

    K Number: K133290 · Decision May 1, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    187
    Applicant Total
    6
    Review Days
    188

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    Basic Information

    Device Name
    COLLACARE DENTAL
    K Number
    K133290
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Innocoll Pharmaceuticals
    Date Received
    October 25, 2013
    Decision Date
    May 1, 2014
    Product Code
    KGN
    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
    KGN Wound Dressing With Animal-Derived Material(S)

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    Other Clearances by Innocoll Pharmaceuticals

    K Number Device Name
    K120339 PROCOLL
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