BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

    TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE

    K Number: K041511 · Decision Jun 3, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    84
    Applicant Total
    5
    Review Days
    361

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    Basic Information

    Device Name
    TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE
    K Number
    K041511
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5010
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sutures India Private Limited
    Date Received
    June 7, 2004
    Decision Date
    June 3, 2005
    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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    Other Clearances by Sutures India Private Limited

    K Number Device Name
    K041514 TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE
    K041512 NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE
    K041510 TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE
    K041515 TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE