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

    TRICOS A RESORBABLE SUBSTITUTE

    K Number: K081721 · Decision Aug 6, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    229
    Applicant Total
    505
    Review Days
    49

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    Basic Information

    Device Name
    TRICOS A RESORBABLE SUBSTITUTE
    K Number
    K081721
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baxter Healthcare Corp
    Date Received
    June 18, 2008
    Decision Date
    August 6, 2008
    Product Code
    LYC
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LYC Bone Grafting Material, Synthetic

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