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

    HYDRO-SIL(TM) COATED GUIDEWIRES

    K Number: K900822 · Decision Jul 17, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    3
    Review Days
    146

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    Basic Information

    Device Name
    HYDRO-SIL(TM) COATED GUIDEWIRES
    K Number
    K900822
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3550
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    National-Standard Medical Products
    Date Received
    February 21, 1990
    Decision Date
    July 17, 1990
    Product Code
    DOX
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DOX Fluorometer, Lead (Dedicated Instruments)

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    Other Clearances by National-Standard Medical Products

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    K896605 KOPANS STABILIZED NEEDLE ASPIRATION GUIDE (SNAG)
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