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

    NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE

    K Number: K010909 · Decision Apr 9, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    84
    Applicant Total
    4
    Review Days
    14

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    Basic Information

    Device Name
    NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
    K Number
    K010909
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.5010
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tyco Healthcare Group LP
    Date Received
    March 26, 2001
    Decision Date
    April 9, 2001
    Product Code
    GAW
    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
    GAW Suture, Nonabsorbable, Synthetic, Polypropylene

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