BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent for Some Indications 🇺🇸 United States

    DERMATEC BURN PADS

    K Number: K863379 · Decision Sep 26, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    502
    Registration Numbers
    502
    Same Product Code
    106
    Applicant Total
    4
    Review Days
    23

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    Basic Information

    Device Name
    DERMATEC BURN PADS
    K Number
    K863379
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4020
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Dermatec, Inc.
    Date Received
    September 3, 1986
    Decision Date
    September 26, 1986
    Product Code
    NAD
    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
    NAD Dressing, Wound, Occlusive

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    Other Clearances by Dermatec, Inc.

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