BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS

    K Number: K972013 · Decision Aug 26, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    57
    Applicant Total
    7
    Review Days
    88

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    Basic Information

    Device Name
    NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS
    K Number
    K972013
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    National Healthcare Mfg. Corp.
    Date Received
    May 30, 1997
    Decision Date
    August 26, 1997
    Product Code
    KNA
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KNA Instrument, Manual, Specialized Obstetric-Gynecologic

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    Other Clearances by National Healthcare Mfg. Corp.

    K Number Device Name
    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
    K960566 NHMC FOLEY CATHETERIZATION TRAY