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

    Endoform Silver Dermal Template

    K Number: K172318 · Decision Nov 17, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    2
    Review Days
    108

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    Basic Information

    Device Name
    Endoform Silver Dermal Template
    K Number
    K172318
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aroa Biosurgery
    Date Received
    August 1, 2017
    Decision Date
    November 17, 2017
    Product Code
    FRO
    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
    FRO Dressing, Wound, Drug

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    Other Clearances by Aroa Biosurgery

    K Number Device Name
    K171231 Endoform Topical Matrix