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

    MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE

    K Number: K954940 · Decision Jan 17, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    93
    Registration Numbers
    93
    Same Product Code
    25
    Applicant Total
    8
    Review Days
    79

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    Basic Information

    Device Name
    MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE
    K Number
    K954940
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mdt Biologic Co.
    Date Received
    October 30, 1995
    Decision Date
    January 17, 1996
    Product Code
    FTA
    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
    FTA Light, Surgical, Accessories

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