BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇰🇷 South Korea

    LATEX FINGER COTS

    K Number: K903073 · Decision Sep 12, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    62

    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
    LATEX FINGER COTS
    K Number
    K903073
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Dongkuk Trading Co., Ltd.
    Date Received
    July 12, 1990
    Decision Date
    September 12, 1990
    Product Code
    LZB
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZB Finger Cot

    Similar 510(k) Clearances

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

    ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PERCUGUARD

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BETHEL PLUS MULTIPLE NAMES

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