BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇦 Canada

    KerraContact Ag Perf Advanced Perforated Silver Wound Dressing

    K Number: K182680 · Decision Dec 6, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    7
    Review Days
    71

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    Basic Information

    Device Name
    KerraContact Ag Perf Advanced Perforated Silver Wound Dressing
    K Number
    K182680
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Exciton Technologies, Inc.
    Date Received
    September 26, 2018
    Decision Date
    December 6, 2018
    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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