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

    TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE

    K Number: K081003 · Decision Jun 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    4
    Review Days
    62

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    Basic Information

    Device Name
    TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE
    K Number
    K081003
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4493
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sutures India Pvt., Ltd.
    Date Received
    April 8, 2008
    Decision Date
    June 9, 2008
    Product Code
    GAM
    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
    GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

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    Other Clearances by Sutures India Pvt., Ltd.

    K Number Device Name
    K081002 MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE
    K081001 PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE
    K060018 TRULENE MESH