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

    IRRIGATION, ASPIRATION TUBING SETS

    K Number: K841072 · Decision Mar 29, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    12
    Review Days
    17

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    Basic Information

    Device Name
    IRRIGATION, ASPIRATION TUBING SETS
    K Number
    K841072
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Innovative Surgical Products, Inc.
    Date Received
    March 12, 1984
    Decision Date
    March 29, 1984
    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 Innovative Surgical Products, Inc.

    K Number Device Name
    K843041 HESLIN DISPOS. TUBING SET
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    K840694 LENS INSERTION GLIDE
    K832235 DISPOSABLE VITRECTOMY HANDPIECE
    K821496 DISPOSABLE IRRIGA/ASPIR. SYSTEM
    K820765 PLEURAL DRAINAGE RESERVOIR
    K820680 DISPOSABLE TUBING SETS
    K802973 ISPVAC TM
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