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

    OXBORO-MEDICAL CAUTERY TIP CLEANER

    K Number: K952784 · Decision Jul 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    23
    Applicant Total
    6
    Review Days
    24

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    Basic Information

    Device Name
    OXBORO-MEDICAL CAUTERY TIP CLEANER
    K Number
    K952784
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4115
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Oxboro Medical Intl., Inc.
    Date Received
    June 19, 1995
    Decision Date
    July 13, 1995
    Product Code
    HQP
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQP Unit, Cautery, Thermal, Battery-Powered

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    Other Clearances by Oxboro Medical Intl., Inc.

    K Number Device Name
    K953068 OXBORO-MEDICAL FOAM INSTRUMENT HOLDER
    K952787 FOAM INSTRUMENT GUARD
    K952783 OXBORO-MEDICAL PIN COVERS
    K880028 OMED DISPOSABLE SCALPEL
    K874813 OMED WOUND CLOSURE STRIPS