BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BARI-KAD PACKING DEVICE

    K Number: K050318 · Decision Mar 4, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    110
    Registration Numbers
    110
    Same Product Code
    32
    Applicant Total
    1
    Review Days
    23

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    Basic Information

    Device Name
    BARI-KAD PACKING DEVICE
    K Number
    K050318
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6300
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bioenvelop Agro, Inc.
    Date Received
    February 9, 2005
    Decision Date
    March 4, 2005
    Product Code
    EIE
    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
    EIE Dam, Rubber

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