BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇳🇿 New Zealand

    Endoform Topical Matrix

    K Number: K171231 · Decision Jun 14, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    187
    Applicant Total
    2
    Review Days
    48

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    Basic Information

    Device Name
    Endoform Topical Matrix
    K Number
    K171231
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aroa Biosurgery
    Date Received
    April 27, 2017
    Decision Date
    June 14, 2017
    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 Aroa Biosurgery

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    K172318 Endoform Silver Dermal Template