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

    RUBBER BAND, STERILE

    K Number: K882695 · Decision Oct 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    24
    Applicant Total
    10
    Review Days
    108

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    Basic Information

    Device Name
    RUBBER BAND, STERILE
    K Number
    K882695
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5410
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Bioseal
    Date Received
    June 27, 1988
    Decision Date
    October 13, 1988
    Product Code
    ECI
    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
    ECI Band, Elastic, Orthodontic

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    Other Clearances by Bioseal

    K Number Device Name
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    K882710 INTESTINAL SPONGES
    K882708 GAUZE SPONGE, X-RAY DETECTABLE
    K882709 TONSIL SPONGE, X-RAY DETECTABLE, W/STRING
    K882707 GAUZE PACKING, X-RAY DETECTABLE
    K882711 GAUZE SPONGE 12PLY
    K882712 STICK SPONGE