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

    DERMAGRAN WET DRESSING (ZINC-SALINE)

    K Number: K913344 · Decision Jul 14, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    144
    Applicant Total
    22
    Review Days
    354

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    Basic Information

    Device Name
    DERMAGRAN WET DRESSING (ZINC-SALINE)
    K Number
    K913344
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Derma Sciences, Inc.
    Date Received
    July 26, 1991
    Decision Date
    July 14, 1992
    Product Code
    MGQ
    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
    MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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    Other Clearances by Derma Sciences, Inc.

    K Number Device Name
    K150985 Medihoney Wound Gel
    K133279 MEDIHONEY WOUND DRESSINGS
    K110546 MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY
    K101793 MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY
    K081584 DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
    K080315 DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
    K072956 MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY
    K970660 DERMAGRAN WOUND MANAGEMENT SYSTEM
    K963603 DERMAGRAN HYDROPHILIC OINTMENT
    K954739 DERMAGRAN HYDROPHILIC OINTMENT
    Search all 22 clearances from Derma Sciences, Inc. →