BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652

    K Number: K010442 · Decision Mar 8, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    71
    Applicant Total
    5
    Review Days
    22

    Basic Information

    Device Name
    KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652
    K Number
    K010442
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    874.3450
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    HEINZ KURZ
    Date Received
    February 14, 2001
    Decision Date
    March 8, 2001
    Product Code
    ETB
    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
    ETB Prosthesis, Partial Ossicular Replacement

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    Other Clearances by HEINZ KURZ

    K Number Device Name
    K991324 TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)
    K990923 TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010
    K973356 K-PISTON WITH BAND HOOK /ANGULAR PISTON
    K972492 BELL PROSTHESIS (PARTIAL)