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

    FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGE

    K Number: K050757 · Decision Feb 23, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    221
    Applicant Total
    6
    Review Days
    337

    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
    FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGE
    K Number
    K050757
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5090
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chemence Medical, Inc.
    Date Received
    March 23, 2005
    Decision Date
    February 23, 2006
    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 Chemence Medical, Inc.

    K Number Device Name
    K212246 Exofin Precision Pen
    K200264 Exofin High Viscosity Topical Skin Adhesive
    K191461 Exofin Fusion Skin Closure System
    K171442 Exofin Fusion Skin Closure System
    K162352 derma+flex QS High Viscosity Tissue Adhesive