BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SILASTIC BRAND INTRAVAGINAL TARSETTE

    K Number: K771548 · Decision Nov 7, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    40
    Applicant Total
    31
    Review Days
    87

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    Basic Information

    Device Name
    SILASTIC BRAND INTRAVAGINAL TARSETTE
    K Number
    K771548
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.3575
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Dow Corning Corp. Healthcare Industries Materials
    Date Received
    August 12, 1977
    Decision Date
    November 7, 1977
    Product Code
    HHW
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HHW Pessary, Vaginal

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    Other Clearances by Dow Corning Corp. Healthcare Industries Materials

    K Number Device Name
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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.)
    K811679 SILASTIC TENDON PASSER H.P.
    Search all 31 clearances from Dow Corning Corp. Healthcare Industries Materials →