BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY

    K Number: K072956 · Decision Nov 7, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    22
    Review Days
    19

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    Basic Information

    Device Name
    MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY
    K Number
    K072956
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Derma Sciences, Inc.
    Date Received
    October 19, 2007
    Decision Date
    November 7, 2007
    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 Derma Sciences, Inc.

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    K101793 MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY
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    K970660 DERMAGRAN WOUND MANAGEMENT SYSTEM
    K963603 DERMAGRAN HYDROPHILIC OINTMENT
    K954739 DERMAGRAN HYDROPHILIC OINTMENT
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