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

    SCITECH BI-MANUAL ADAPTER CLIPS

    K Number: K910088 · Decision Apr 8, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    89

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    Basic Information

    Device Name
    SCITECH BI-MANUAL ADAPTER CLIPS
    K Number
    K910088
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4100
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Scitech Industries Partnership
    Date Received
    January 9, 1991
    Decision Date
    April 8, 1991
    Product Code
    HQQ
    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
    HQQ Apparatus, Cautery, Radiofrequency, Battery-Powered

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