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

    HEPATOSTAT SET

    K Number: K073493 · Decision May 6, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    48
    Review Days
    146

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    Basic Information

    Device Name
    HEPATOSTAT SET
    K Number
    K073493
    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
    Vygon Corp.
    Date Received
    December 12, 2007
    Decision Date
    May 6, 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 Vygon Corp.

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    K060944 NUTRISAFE 2
    K062425 LIFECATH S PICC AND MIDLINE CATHETER
    K052564 VYGON LEADER-FLEX
    K052881 VYGON LATEX FREE BIONECTOR
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