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

    MANUAL IRRIGATING/ASPIRATING UNIT

    K Number: K840495 · Decision Jun 19, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    5
    Review Days
    134

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    Basic Information

    Device Name
    MANUAL IRRIGATING/ASPIRATING UNIT
    K Number
    K840495
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Alltek, Inc.
    Date Received
    February 6, 1984
    Decision Date
    June 19, 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 Alltek, Inc.

    K Number Device Name
    K854172 I.V. WATCH
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    K852030 PEDIATRIC IV WATCH
    K834376 FILTRARE TM ALLVENT TM