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

    ECHO-COAT ULTRASOUND NEEDLES

    K Number: K983647 · Decision Jan 20, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    96

    Basic Information

    Device Name
    ECHO-COAT ULTRASOUND NEEDLES
    K Number
    K983647
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    STS BIOPOLYMERS
    Date Received
    October 16, 1998
    Decision Date
    January 20, 1999
    Product Code
    MJG
    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
    MJG Device, Percutaneous, Biopsy

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