BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    COVAMAX RESORBABLE COLLAGEN MEMBRANE

    K Number: K103087 · Decision Aug 26, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    56
    Applicant Total
    2
    Review Days
    311

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    Basic Information

    Device Name
    COVAMAX RESORBABLE COLLAGEN MEMBRANE
    K Number
    K103087
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biom'Up Sas
    Date Received
    October 19, 2010
    Decision Date
    August 26, 2011
    Product Code
    NPL
    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
    NPL Barrier, Animal Source, Intraoral

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    Other Clearances by Biom'Up Sas

    K Number Device Name
    K103081 COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE