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

    PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP

    K Number: K000542 · Decision Apr 28, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    29
    Applicant Total
    7
    Review Days
    71

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    Basic Information

    Device Name
    PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP
    K Number
    K000542
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4830
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arc Medical Supplies (Beijing) Co, Ltd.
    Date Received
    February 17, 2000
    Decision Date
    April 28, 2000
    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 Arc Medical Supplies (Beijing) Co, Ltd.

    K Number Device Name
    K022666 PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.
    K022664 PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.
    K000541 SILK NONABSORBABLE SURGICAL SUTURES, USP
    K000540 POLYESTER NONABSORBABLE SURGICAL SUTURES, USP
    K000537 POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP
    K000539 NYLON NONABSORBABLE SURGICAL SUTURES, USP