BEUDAMED
    Product Code: MSA FDA class 1 21 CFR 878.4020

    Dressing, Wound And Burn, Occlusive, Heated

    General, Plastic Surgery

    A Heated Occlusive Wound and Burn Dressing is a wound care device that provides a sealed, moisture-retentive covering combined with thermal warming properties, intended to promote healing of wounds and burns. It is classified as FDA Class 1, subject to general controls but not exempt from GMP requirements, meaning it must comply with standard quality system regulations without needing a premarket submission. The product code is MSA, regulated under 21 CFR 878.4020 in the General and Plastic Surgery specialty. The device is not an implant and is not life-sustaining.

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    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    5

    Basic Information

    Product Code
    MSA
    Device Class
    FDA class 1
    Regulation Number
    878.4020
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    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
    K020077 MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX
    K963293 AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX