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

    FOAM INSTRUMENT GUARD

    K Number: K952787 · Decision Dec 28, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    6
    Review Days
    192

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    Basic Information

    Device Name
    FOAM INSTRUMENT GUARD
    K Number
    K952787
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Oxboro Medical Intl., Inc.
    Date Received
    June 19, 1995
    Decision Date
    December 28, 1995
    Product Code
    KCT
    Advisory Committee
    General Hospital
    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
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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    Other Clearances by Oxboro Medical Intl., Inc.

    K Number Device Name
    K953068 OXBORO-MEDICAL FOAM INSTRUMENT HOLDER
    K952783 OXBORO-MEDICAL PIN COVERS
    K952784 OXBORO-MEDICAL CAUTERY TIP CLEANER
    K880028 OMED DISPOSABLE SCALPEL
    K874813 OMED WOUND CLOSURE STRIPS