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

    SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK

    K Number: K050648 · Decision Apr 5, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    8
    Review Days
    22

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    Basic Information

    Device Name
    SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK
    K Number
    K050648
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Medical Optics, Inc.
    Date Received
    March 14, 2005
    Decision Date
    April 5, 2005
    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 Advanced Medical Optics, Inc.

    K Number Device Name
    K081681 VITRECTOMY CUTTER AND ACCESSORIES
    K081545 ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30
    K060366 THE AMO OPHTHALMIC SURGICAL SYSTEM
    K042562 LENS PLUS REWETTING DROPS
    K040839 COMPLETE BLINK-N-CLEAN LENS DROPS
    K032030 BLINK CL LUBRICANT EYE DROPS
    K030092 COMPLETE BRAND MULTI-PURPOSE SOLUTION