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

    HEMOSLEEVE, MODEL 4.0MM, 5.5MM

    K Number: K984018 · Decision Mar 15, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    51
    Review Days
    123

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    Basic Information

    Device Name
    HEMOSLEEVE, MODEL 4.0MM, 5.5MM
    K Number
    K984018
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Laser Technologies, Inc.
    Date Received
    November 12, 1998
    Decision Date
    March 15, 1999
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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