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

    NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS

    K Number: K971317 · Decision May 8, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    329
    Registration Numbers
    330
    Same Product Code
    61
    Applicant Total
    7
    Review Days
    29

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    Basic Information

    Device Name
    NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS
    K Number
    K971317
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    National Healthcare Mfg. Corp.
    Date Received
    April 9, 1997
    Decision Date
    May 8, 1997
    Product Code
    KDD
    Advisory Committee
    General, Plastic Surgery
    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
    KDD Kit, Surgical Instrument, Disposable

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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
    K962670 NHMC IRRIGATION TRAY
    K962254 NHMC URETHRAL CATHETERIZATION TRAY
    K960523 NHMC DRESSING TRAY
    K960566 NHMC FOLEY CATHETERIZATION TRAY