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

    SOF-SUCTION FLUID EVACUATION SYSTEM

    K Number: K990749 · Decision Apr 2, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    78
    Same Product Code
    46
    Applicant Total
    1
    Review Days
    25

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    Basic Information

    Device Name
    SOF-SUCTION FLUID EVACUATION SYSTEM
    K Number
    K990749
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4790
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    X-Tech Medical, LLC
    Date Received
    March 8, 1999
    Decision Date
    April 2, 1999
    Product Code
    HOZ
    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
    HOZ Sponge, Ophthalmic

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