BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    RNG SERIES ULTRASOUND NEEDLE/CATH. GDS

    K Number: K820269 · Decision Mar 23, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    10
    Applicant Total
    29
    Review Days
    49

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    Basic Information

    Device Name
    RNG SERIES ULTRASOUND NEEDLE/CATH. GDS
    K Number
    K820269
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    CIVCO Medical Instruments Co., Inc.
    Date Received
    February 2, 1982
    Decision Date
    March 23, 1982
    Product Code
    DWO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DWO Needle, Biopsy, Cardiovascular

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