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

    OPPORTUNITY DRESSING CHANGE TRAY

    K Number: K971090 · Decision Sep 16, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    221
    Applicant Total
    8
    Review Days
    176

    Basic Information

    Device Name
    OPPORTUNITY DRESSING CHANGE TRAY
    K Number
    K971090
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5090
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    OPPORTUNITY, INC.
    Date Received
    March 24, 1997
    Decision Date
    September 16, 1997
    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 OPPORTUNITY, INC.

    K Number Device Name
    K971089 OPPORTUNITY, INC. LACERATION TRAY
    K971093 OPPORTUNITY I.V. START KIT
    K971095 OPPORTUNITY SUTURE REMOVAL KIT
    K971088 OPPORTUNITY INCISION AND DRAINAGE TRAY
    K971091 OPPURTUNITY TRACHEOSTOMY CARE KIT
    K971061 OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY
    K971062 OPPORTUNITY INC. GENERAL PURPOSE TRAY