BEUDAMED
    Product Code: SEK FDA unclassified

    Wound Dressings With Hydrocortisone

    Unknown
    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    0

    Basic Information

    Product Code
    SEK
    Device Class
    FDA unclassified
    Medical Specialty
    Unknown
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

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

    Definition

    A wound dressing containing hydrocortisone is used to maintain appropriate moisture balance within the wound

    Unclassified Reason

    1

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

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

    K Number Device Name
    K883619 MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL
    K883566 MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL