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

    NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS

    K Number: K971465 · Decision Jun 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    712
    Registration Numbers
    712
    Same Product Code
    54
    Applicant Total
    7
    Review Days
    43

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    Basic Information

    Device Name
    NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS
    K Number
    K971465
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4750
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    National Healthcare Mfg. Corp.
    Date Received
    April 22, 1997
    Decision Date
    June 4, 1997
    Product Code
    HOY
    Advisory Committee
    Ophthalmic
    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
    HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

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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
    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