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    K Number
    K062540
    Device Name
    NASOPORE EAR, MODELS ND04, ND05
    Manufacturer
    Polyganics BV
    Date Cleared
    2006-10-18

    (49 days)

    Product Code
    KCN
    Regulation Number
    874.5220
    Why did this record match?
    Product Code :

    KCN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nasopore® Ear is a fragmentable ear packing and is indicated for use in patients, undergoing outer ear surgery, as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding, following ear surgery, by tamponade effect and blood absorption.
    Device Description
    Nasopore® Ear is composed of a bioresorbable poly(DL-lactide-co-sscription caprolactone) urethane that fragments within several days after insertion in the outer ear, whereafter it is drained from the cavity. The type of Nasopore® Ear is indicated on the label. Nasopore® Ear is packed in a blister closed by a medical paper lid. Nasopore® Ear is indicated for single-use.
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    K Number
    K973578
    Device Name
    INVOTEC EAR TAMPON (WICK) W/STRING
    Manufacturer
    INVOTEC INTERNATIONAL, INC.
    Date Cleared
    1997-11-06

    (48 days)

    Product Code
    KCN
    Regulation Number
    874.5220
    Why did this record match?
    Product Code :

    KCN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Invotec Ear Tampon ( wick ) w/ string, is indicated for use as a ear packing for use after internal ear surgery. The packing is to be used in the ear canal as a surgical packing.
    Device Description
    Invotec Ear Tampon (Wick) w/String
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