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

    SORBSAN PLUS TOPICAL WOUND DRESSING

    K Number: K954230 · Decision Nov 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    221
    Applicant Total
    2
    Review Days
    58

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SORBSAN PLUS TOPICAL WOUND DRESSING
    K Number
    K954230
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5090
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dow Hickam Pharmaceuticals, Inc.
    Date Received
    September 11, 1995
    Decision Date
    November 8, 1995
    Product Code
    KMF
    Advisory Committee
    General Hospital
    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
    KMF Bandage, Liquid

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KMF), ordered by most recent decision date.

    TearRepair Liquid Skin Protectant

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Rochal Bioshield Silicone Film

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Aleo BME Liquid Bandage

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Cavilon Advanced High Endurance Skin Protectant

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Atteris No-Sting Skin Protectant

    FDA 510(k)
    FDA Class 1 ·General Hospital

    KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all

    Other Clearances by Dow Hickam Pharmaceuticals, Inc.

    K Number Device Name
    K954602 FLEXZAN WOUND DRESSING