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

    TUNNELER

    K Number: K943968 · Decision Mar 1, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    840
    Registration Numbers
    840
    Same Product Code
    43
    Applicant Total
    10
    Review Days
    198

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    Basic Information

    Device Name
    TUNNELER
    K Number
    K943968
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Denver Biomedicals, Inc.
    Date Received
    August 15, 1994
    Decision Date
    March 1, 1995
    Product Code
    MDM
    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
    MDM Instrument, Manual, Surgical, General Use

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