Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K965256
    Device Name
    DMS-1000C DERMOABRADER
    Date Cleared
    1996-12-09

    (115 days)

    Product Code
    Regulation Number
    878.4820
    Why did this record match?
    Product Code :

    GFD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

    K Number
    K962371
    Device Name
    DERMTOME BLADE
    Manufacturer
    Date Cleared
    1996-08-29

    (71 days)

    Product Code
    Regulation Number
    878.4820
    Why did this record match?
    Product Code :

    GFD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DSP Worldwide Snowden-Pencer Dermatome Blade is intended for use as an accessory to Padgett type dermatomes.
    Device Description
    The DSP Worldwide Snowden-Pencer Dermatome Blade is secured to the Padgett Dermatome head using the securing nut. The blade oscillates on the horizontal plane to harvest a split thickness of skin from a donor site for grafting. It is provided in one size only and consists of the stainless steel used for many surgical applications. Blades are provided sterile, single use, and disposable in individual Tyvek and polypropylene pouches. Devices are sterilized using gamma sterilization.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1