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

    STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES

    K Number: K971439 · Decision Jun 17, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    101
    Review Days
    60

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    Basic Information

    Device Name
    STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES
    K Number
    K971439
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Storz Instrument Co.
    Date Received
    April 18, 1997
    Decision Date
    June 17, 1997
    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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