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

    MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM

    K Number: K912904 · Decision Jun 11, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    18
    Review Days
    345

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    Basic Information

    Device Name
    MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM
    K Number
    K912904
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mentor O & O, Inc.
    Date Received
    July 2, 1991
    Decision Date
    June 11, 1992
    Product Code
    HQC
    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
    HQC Unit, Phacofragmentation

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    Other Clearances by Mentor O & O, Inc.

    K Number Device Name
    K955245 MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM
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    K915340 MENTOR HORIZON LOW VISION MAGNIFIER
    K910637 MENTOR(R) SUR-E-TROL(R)
    K911160 MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305
    K903878 MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT
    K895010 MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE
    K890622 SURG-E-TROL SYSTEM I AND SYSTEM II
    K890595 MENTOR ANTERIOR SEGMENT VITRECTOR
    K881001 MENTOR WET-FIELD*II COAGULATOR
    Search all 18 clearances from Mentor O & O, Inc. →