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

    POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING

    K Number: K063536 · Decision Jan 29, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    2
    Review Days
    68

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    Basic Information

    Device Name
    POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING
    K Number
    K063536
    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
    Tyco Healthcare Group
    Date Received
    November 22, 2006
    Decision Date
    January 29, 2007
    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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