BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BLOM-SINGER INDWELLING TEP OCCLUDER

    K Number: K093258 · Decision Mar 3, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    39
    Applicant Total
    4
    Review Days
    135

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    Basic Information

    Device Name
    BLOM-SINGER INDWELLING TEP OCCLUDER
    K Number
    K093258
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    874.3730
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Helix Medical, LLC
    Date Received
    October 19, 2009
    Decision Date
    March 3, 2010
    Product Code
    EWL
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EWL Prosthesis, Laryngeal (Taub)

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    Other Clearances by Helix Medical, LLC

    K Number Device Name
    K130736 BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS
    K131745 BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
    K082206 BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES