BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PDM SILOXANE PROSTHETIC EAR

    K Number: K832152 · Decision Dec 9, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    16
    Applicant Total
    5
    Review Days
    157

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    Basic Information

    Device Name
    PDM SILOXANE PROSTHETIC EAR
    K Number
    K832152
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.3800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Delaware Prosthetics, Inc.
    Date Received
    July 5, 1983
    Decision Date
    December 9, 1983
    Product Code
    GBI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GBI Material, External Aesthetic Restoration, Used With Adhesive

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    Other Clearances by Delaware Prosthetics, Inc.

    K Number Device Name
    K832151 PDM SILOXANE PROSTHETIC ORBIT
    K832153 PDM SILOXANE PROSTHETIC NOSE
    K832149 PDM SILOXANE PROSTHETIC OBTURATOR
    K832148 PDM SILOXANE PROSTHETIC CHIN IMPLANT