BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    The Graft Bone Substitute

    K Number: K191737 · Decision Feb 14, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    39
    Applicant Total
    6
    Review Days
    231

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    Basic Information

    Device Name
    The Graft Bone Substitute
    K Number
    K191737
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Purgo Biologics, Inc.
    Date Received
    June 28, 2019
    Decision Date
    February 14, 2020
    Product Code
    NPM
    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
    NPM Bone Grafting Material, Animal Source

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