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

    BURKE CONGENITAL THORACOSCOPY INSTRUMENTS

    K Number: K962771 · Decision Nov 19, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    313
    Registration Numbers
    313
    Same Product Code
    70
    Applicant Total
    6
    Review Days
    126

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    Basic Information

    Device Name
    BURKE CONGENITAL THORACOSCOPY INSTRUMENTS
    K Number
    K962771
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.4500
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pilling Weck, Inc.
    Date Received
    July 16, 1996
    Decision Date
    November 19, 1996
    Product Code
    DWS
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DWS Instruments, Surgical, Cardiovascular

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