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

    CILCO I/A SURGICAL PACK

    K Number: K843319 · Decision Feb 14, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    12
    Review Days
    174

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    Basic Information

    Device Name
    CILCO I/A SURGICAL PACK
    K Number
    K843319
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Cilco, Inc.
    Date Received
    August 24, 1984
    Decision Date
    February 14, 1985
    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 Cilco, Inc.

    K Number Device Name
    K861334 CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE
    K854969 CILCO SONOMETRICS A&B DIGITAL SYSTEM (DIGISCAN)
    K844249 K-SOL
    K843992 CILCOR OPHTHALMIC INSTRUMENTS
    K843447 CILCO DIAMOND KNIFE
    K841099 OCTOPUS 500/500E
    K840475 CYSTOTOME, 140-S
    K832405 OPTHALMIC ENDOSCOPE
    K827371 CILCO ASCAN
    K820933 CILCO I/A HANDPIECE
    Search all 12 clearances from Cilco, Inc. →