BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PATCHASSIST LARGE

    K Number: K103269 · Decision Nov 23, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    19

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    Basic Information

    Device Name
    PATCHASSIST LARGE
    K Number
    K103269
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Polytouch Medical, Ltd.
    Date Received
    November 4, 2010
    Decision Date
    November 23, 2010
    Product Code
    ORQ
    Advisory Committee
    General, Plastic Surgery
    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
    ORQ Mesh, Surgical, Deployer

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    Other Clearances by Polytouch Medical, Ltd.

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    K101218 PATCHASSIST