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

    SCHEIN COTTON ROLLS, NON-STERILE

    K Number: K834056 · Decision Feb 3, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    206
    Registration Numbers
    206
    Same Product Code
    13
    Applicant Total
    8
    Review Days
    72

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    Basic Information

    Device Name
    SCHEIN COTTON ROLLS, NON-STERILE
    K Number
    K834056
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6050
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Henry Schein, Inc.
    Date Received
    November 23, 1983
    Decision Date
    February 3, 1984
    Product Code
    EFN
    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
    EFN Cotton, Roll

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