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

    KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING

    K Number: K973509 · Decision Dec 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    221
    Applicant Total
    66
    Review Days
    79

    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
    KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
    K Number
    K973509
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5090
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Kendall Healthcare Products Co. Div.Of Tyco Health
    Date Received
    September 16, 1997
    Decision Date
    December 4, 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 Kendall Healthcare Products Co. Div.Of Tyco Health

    K Number Device Name
    K973763 KENDALL CURITY IODOFORM PACKING STRIP
    K973511 KENDALL CURITY PETROLATUM GAUZE
    K973507 KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)
    K973619 KENDALL CURITY NON-ADHERING DRESSING
    K973546 KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER
    K970266 KENDALL HYDROPHILIC POWDER WOUND DRESSING
    K963446 KENDALL DUAL LUMEN CATHETER
    K964899 KENDALL CURITY URETERAL CATHETER
    K964519 CURITY THORACENTESIS TRAY
    K961977 KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE
    Search all 66 clearances from Kendall Healthcare Products Co. Div.Of Tyco Health →