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

    NHMC FOLEY CATHETERIZATION TRAY

    K Number: K960566 · Decision Feb 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    59
    Applicant Total
    7
    Review Days
    20

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    Basic Information

    Device Name
    NHMC FOLEY CATHETERIZATION TRAY
    K Number
    K960566
    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
    February 9, 1996
    Decision Date
    February 29, 1996
    Product Code
    FCM
    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
    FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

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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
    K962670 NHMC IRRIGATION TRAY
    K962254 NHMC URETHRAL CATHETERIZATION TRAY
    K960523 NHMC DRESSING TRAY