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

    BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS

    K Number: K991587 · Decision Jun 25, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    39
    Applicant Total
    14
    Review Days
    49

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    Basic Information

    Device Name
    BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS
    K Number
    K991587
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3730
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Helix Medical, Inc.
    Date Received
    May 7, 1999
    Decision Date
    June 25, 1999
    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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    K932120 BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES
    K932163 BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET
    K930105 BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.
    K920090 BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET
    K915786 BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID.
    K904729 BLOM-SINGER SHOWER GUARD
    K902112 BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENT
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