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

    LAPAROSCOPIC RETRACTOR SYSTEM

    K Number: K921006 · Decision Jul 28, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    8
    Applicant Total
    10
    Review Days
    147

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    Basic Information

    Device Name
    LAPAROSCOPIC RETRACTOR SYSTEM
    K Number
    K921006
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Laparomed Corp.
    Date Received
    March 3, 1992
    Decision Date
    July 28, 1992
    Product Code
    GCS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCS Endoscope, Battery-Powered And Accessories

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