LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    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?
    Search-Everything :

    Matched: '874.5220'

    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.
    Ask a Question
    K Number
    K984345
    Device Name
    AROMAPATCH
    Manufacturer
    ENVIS, INC.
    Date Cleared
    1999-03-19

    (105 days)

    Product Code
    LRD
    Regulation Number
    874.5220
    Why did this record match?
    Search-Everything :

    Matched: '874.5220'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aromapatch™ nasal inhaler shall be single use only and are to be used by the general public as a medium for aroma inhalation of essential oils, such as eucalyptus oil.
    Device Description
    Aromapatch™ nasal inhaler
    Ask a Question

    Page 1 of 1