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

    LU-TEX II

    K Number: K904535 · Decision Jan 30, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    16
    Applicant Total
    8
    Review Days
    118

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    Basic Information

    Device Name
    LU-TEX II
    K Number
    K904535
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5000
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Lukens Medical Corp.
    Date Received
    October 4, 1990
    Decision Date
    January 30, 1991
    Product Code
    GAS
    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
    GAS Suture, Nonabsorbable, Synthetic, Polyester

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    Other Clearances by Lukens Medical Corp.

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    K930942 LUKENS SILK SURGICAL SUTURE
    K930945 BRAIDED POLYESTER SURGICAL SUTURE
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