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

    SEWON DENTAL FLOSS FOLDER

    K Number: K842846 · Decision Aug 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    335
    Registration Numbers
    336
    Same Product Code
    61
    Applicant Total
    7
    Review Days
    28

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    Basic Information

    Device Name
    SEWON DENTAL FLOSS FOLDER
    K Number
    K842846
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6390
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Sewon Industry
    Date Received
    July 20, 1984
    Decision Date
    August 17, 1984
    Product Code
    JES
    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
    JES Floss, Dental

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    K811926 SE WON(ALUMINUM) DENTAL FLOSS HOLDER
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