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

    SYNERGIST POWER PACK

    K Number: K960414 · Decision Apr 24, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    34
    Review Days
    86

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    Basic Information

    Device Name
    SYNERGIST POWER PACK
    K Number
    K960414
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chiron Vision Corp.
    Date Received
    January 29, 1996
    Decision Date
    April 24, 1996
    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 Chiron Vision Corp.

    K Number Device Name
    K970727 MPORT FOLDABLE LENS PLACEMENT SYSTEM
    K972808 HANSATOME MICROKERATOME
    K944993 IOLAB.SITE CD PHACOEMULSIFICATION MODULE
    K944995 IOLAB/SITE PERISTALTIC MODULE
    K951292 PASSPORT FOLDABLE LENS PLACEMENT SYSTEM
    K944994 IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE
    K941550 AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT
    K935233 IOLAB LACRIMAL DUCT CATHETER
    K925606 OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS
    K926412 MICRON-SCOPE II
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