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

    PANJE VOICE PROSTHESIS

    K Number: K810020 · Decision Feb 5, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    39
    Applicant Total
    82
    Review Days
    31

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    Basic Information

    Device Name
    PANJE VOICE PROSTHESIS
    K Number
    K810020
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3730
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Xomed, Inc.
    Date Received
    January 5, 1981
    Decision Date
    February 5, 1981
    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 Xomed, Inc.

    K Number Device Name
    K002395 MODEL 30 CLASSIC PNEUMATONOMETER
    K002987 REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE
    K002828 XPS NITRO SYSTEM
    K002897 TITANIUM MIDDLE EAR PROSTHESES
    K993653 MICRO-FRANCE TROCARS AND ACCESSORIES
    K001148 MEROGEL OTOLOGIC PACK
    K994262 FRONTAL SINUS TREPHINATION CANNULA
    K992855 XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT
    K993582 MODIFICATION TO LASER-SHIELD II
    K993655 MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS
    Search all 82 clearances from Xomed, Inc. →