BEUDAMED
    Product Code: LZM FDA class 1 21 CFR 878.4014

    Guard, Skin Graft

    General, Plastic Surgery

    The Skin Graft Guard (product code LZM) is a surgical device used to protect a freshly applied skin graft and maintain it in position during the healing process, preventing displacement and promoting adherence to the wound bed. Regulated under 21 CFR 878.4014 and classified as a Class 1 device subject only to general controls, it falls under the General and Plastic Surgery specialty. It is not an implant, is not life-sustaining, and is not GMP-exempt.

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    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    6

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    Basic Information

    Product Code
    LZM
    Device Class
    FDA class 1
    Regulation Number
    878.4014
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K943871 AQUAPLAST TIE DOWN DRESSING
    K885136 GRAFT GUARD