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

    PROSIT WOUND TREATMENT DEVICE

    K Number: K081977 · Decision Dec 1, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    2
    Review Days
    143

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    Basic Information

    Device Name
    PROSIT WOUND TREATMENT DEVICE
    K Number
    K081977
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Silverleaf Medical Products, Inc.
    Date Received
    July 11, 2008
    Decision Date
    December 1, 2008
    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 Silverleaf Medical Products, Inc.

    K Number Device Name
    K060237 CMB ANTIMICROBIAL DRESSING