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

    PDM SILOXANE PROSTHETIC OBTURATOR

    K Number: K832149 · Decision Nov 28, 1983
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    5
    Review Days
    146

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    Basic Information

    Device Name
    PDM SILOXANE PROSTHETIC OBTURATOR
    K Number
    K832149
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Applicant
    Delaware Prosthetics, Inc.
    Date Received
    July 5, 1983
    Decision Date
    November 28, 1983
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Other Clearances by Delaware Prosthetics, Inc.

    K Number Device Name
    K832151 PDM SILOXANE PROSTHETIC ORBIT
    K832153 PDM SILOXANE PROSTHETIC NOSE
    K832152 PDM SILOXANE PROSTHETIC EAR
    K832148 PDM SILOXANE PROSTHETIC CHIN IMPLANT