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

    DERMACYN WOUND CARE

    K Number: K060113 · Decision Feb 22, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    7
    Review Days
    36

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    Basic Information

    Device Name
    DERMACYN WOUND CARE
    K Number
    K060113
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oculus Innovative Sciences, Inc.
    Date Received
    January 17, 2006
    Decision Date
    February 22, 2006
    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 Oculus Innovative Sciences, Inc.

    K Number Device Name
    K102945 PEDIACYN ATOPIC DERMATITIS HYDROGEL
    K093585 MICROCYN SKIN AND WOUND HYDROGEL
    K090206 OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER
    K090725 OCULUS MICROCYN WOUND GEL
    K042729 DERMACYN WOUND IRRIGATION
    K041161 MICROCYN WOUND CARE DRESSING