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

    TITANIUM PROBES

    K Number: K852415 · Decision Aug 2, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    656
    Registration Numbers
    656
    Same Product Code
    99
    Applicant Total
    14
    Review Days
    56

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    Basic Information

    Device Name
    TITANIUM PROBES
    K Number
    K852415
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    L.A.S.E.R., Inc.
    Date Received
    June 7, 1985
    Decision Date
    August 2, 1985
    Product Code
    GAD
    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
    GAD Retractor

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    K924844 BULK TISSUE REMOVAL SYSTEM
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    K931092 ENDOSCOPIC RETRACTOR
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