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

    MEDSPEC OPERATIVE OPTHALMIC KIT

    K Number: K800404 · Decision Apr 24, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    16
    Applicant Total
    8
    Review Days
    58

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    Basic Information

    Device Name
    MEDSPEC OPERATIVE OPTHALMIC KIT
    K Number
    K800404
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4440
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Medi-Spec
    Date Received
    February 26, 1980
    Decision Date
    April 24, 1980
    Product Code
    HMP
    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
    HMP Pad, Eye

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    Other Clearances by Medi-Spec

    K Number Device Name
    K833068 LAMINARIA JAPONICA CERVICAL DILATOR
    K812694 WHISK-R
    K812426 UTERINE ASPIRATION CURETTES(RIGID&FLEX)
    K801554 STERILE CAST PADDING
    K800490 STERILE DRESSING PACK
    K790952 CLAMP COVERS
    K780548 DISPOSA-LOOPS