BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    NHMC IRRIGATION TRAY

    K Number: K962670 · Decision Aug 14, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    27
    Applicant Total
    7
    Review Days
    36

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    Basic Information

    Device Name
    NHMC IRRIGATION TRAY
    K Number
    K962670
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    National Healthcare Mfg. Corp.
    Date Received
    July 9, 1996
    Decision Date
    August 14, 1996
    Product Code
    LJH
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LJH System, Irrigation, Urological

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    Other Clearances by National Healthcare Mfg. Corp.

    K Number Device Name
    K972013 NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS
    K971465 NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS
    K971317 NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS
    K962254 NHMC URETHRAL CATHETERIZATION TRAY
    K960523 NHMC DRESSING TRAY
    K960566 NHMC FOLEY CATHETERIZATION TRAY