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

    SILASTIC BRAND PERCUTANEOUS SKIN EXPANDE

    K Number: K801042 · Decision Jun 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    54
    Applicant Total
    31
    Review Days
    55

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    Basic Information

    Device Name
    SILASTIC BRAND PERCUTANEOUS SKIN EXPANDE
    K Number
    K801042
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Dow Corning Corp. Healthcare Industries Materials
    Date Received
    May 2, 1980
    Decision Date
    June 26, 1980
    Product Code
    LCJ
    Advisory Committee
    Unknown
    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
    LCJ Tissue Expander And Accessories

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    Other Clearances by Dow Corning Corp. Healthcare Industries Materials

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    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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    Search all 31 clearances from Dow Corning Corp. Healthcare Industries Materials →