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

    HAND-TROL S

    K Number: K931215 · Decision Mar 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    3
    Applicant Total
    6
    Review Days
    383

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    Basic Information

    Device Name
    HAND-TROL S
    K Number
    K931215
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aspen Labs
    Date Received
    March 10, 1993
    Decision Date
    March 28, 1994
    Product Code
    DWG
    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
    DWG Electrosurgical Device

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