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

    LUKENS SURGICAL GUT SUTURE

    K Number: K930944 · Decision Dec 17, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    29
    Applicant Total
    8
    Review Days
    297

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    Basic Information

    Device Name
    LUKENS SURGICAL GUT SUTURE
    K Number
    K930944
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4830
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Lukens Medical Corp.
    Date Received
    February 23, 1993
    Decision Date
    December 17, 1993
    Product Code
    GAL
    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
    GAL Suture, Absorbable, Natural

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    Other Clearances by Lukens Medical Corp.

    K Number Device Name
    K965162 LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.
    K930941 LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE
    K930942 LUKENS SILK SURGICAL SUTURE
    K930945 BRAIDED POLYESTER SURGICAL SUTURE
    K930943 LUKENS NYLON SURGICAL SUTURE
    K930940 LUKENS STAINLESS STEEL SURGICAL SUTURE
    K904535 LU-TEX II