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

    SAPHIRE PLUS SURGICAL MIRROR

    K Number: K934911 · Decision Jun 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    48
    Applicant Total
    2
    Review Days
    250

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    Basic Information

    Device Name
    SAPHIRE PLUS SURGICAL MIRROR
    K Number
    K934911
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4350
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    San Diego Swiss Machining, Inc.
    Date Received
    October 14, 1993
    Decision Date
    June 21, 1994
    Product Code
    EQH
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EQH Source, Carrier, Fiberoptic Light

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    Other Clearances by San Diego Swiss Machining, Inc.

    K Number Device Name
    K960889 SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPS