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

    SILASTIC NEPHROSTOMY SYSTEM

    K Number: K781664 · Decision Jan 22, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    10
    Applicant Total
    31
    Review Days
    116

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    Basic Information

    Device Name
    SILASTIC NEPHROSTOMY SYSTEM
    K Number
    K781664
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Dow Corning Corp. Healthcare Industries Materials
    Date Received
    September 28, 1978
    Decision Date
    January 22, 1979
    Product Code
    GBO
    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
    GBO Catheter, Nephrostomy, General & Plastic Surgery

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    Other Clearances by Dow Corning Corp. Healthcare Industries Materials

    K Number Device Name
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    K850255 DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET
    K843995 TF-II HIP PROSTHESIS
    K842559 WHITESIDE ORTHOLOC TOTAL HIP FEMORAL
    K840357 SSA HIP PROSTHESIS
    K831479 METAL-BACKED ACETABULAR CUP
    K812864 SILASTIC VOICE PROSTHESIS
    K812053 SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)
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