Search Filters

Search Results

Found 9 results

510(k) Data Aggregation

    K Number
    K974479
    Device Name
    SILIMED VAGINAL STENT
    Manufacturer
    SILIMED, LLC.
    Date Cleared
    1998-08-05

    (252 days)

    Product Code
    KXP
    Regulation Number
    884.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    SILIMED, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Silimed Vaginal Stent is designed to maintain the vaginal canal following radiological treatment or surgical procedures to restore, enlarge or create a vagina. The surgeon is responsible for proper choice of size to meet the clinical and aesthetic needs of each case.
    Device Description
    Silimed Vaginal Stent
    Ask a Question
    K Number
    K981852
    Device Name
    SILIMED TISSUE EXPANDER
    Manufacturer
    SILIMED, LLC.
    Date Cleared
    1998-08-05

    (71 days)

    Product Code
    LCJ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SILIMED, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Silimed Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts, and to aid in the treatment of soft tissue deformities.
    Device Description
    Not Found
    Ask a Question
    K Number
    K981835
    Device Name
    SILIMED MALAR IMPLANT
    Manufacturer
    SILIMED, LLC.
    Date Cleared
    1998-07-09

    (44 days)

    Product Code
    LZK
    Regulation Number
    878.3550
    Why did this record match?
    Applicant Name (Manufacturer) :

    SILIMED, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Silimed Malar Implant is designed to be used for augmentation and reconstruction of the cheek.
    Device Description
    Not Found
    Ask a Question
    K Number
    K981850
    Device Name
    SILIMED CHIN IMPLANTS
    Manufacturer
    SILIMED, LLC.
    Date Cleared
    1998-07-09

    (44 days)

    Product Code
    FWP
    Regulation Number
    878.3550
    Why did this record match?
    Applicant Name (Manufacturer) :

    SILIMED, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Silimed Chin Implants are intended for use in aesthetic, corrective or reconstructive surgery of the chin.
    Device Description
    Not Found
    Ask a Question
    K Number
    K981851
    Device Name
    SILIMED SILICONE CARVING BLOCK
    Manufacturer
    SILIMED, LLC.
    Date Cleared
    1998-07-09

    (44 days)

    Product Code
    MIB
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    SILIMED, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Silimed Silicone Carving Block is designed to be used in aesthetic, corrective or reconstructive surgery. The Silimed Silicone Carving Block allows the surgeon to carve a finished device for his own custom use.
    Device Description
    Silimed Silicone Carving Blocks
    Ask a Question
    K Number
    K981833
    Device Name
    SILIMED NASAL L SHAPED IMPLANT
    Manufacturer
    SILIMED, LLC.
    Date Cleared
    1998-06-26

    (31 days)

    Product Code
    FZE
    Regulation Number
    878.3680
    Why did this record match?
    Applicant Name (Manufacturer) :

    SILIMED, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Silimed Nasal Implant is designed to be used for augmentation and reconstruction of the nasal contour. It is radiopaque and may be trimmed.
    Device Description
    Silimed Nasal "L" Shaped Implant
    Ask a Question
    K Number
    K980221
    Device Name
    SILIMED NASAL RETAINER
    Manufacturer
    SILIMED, LLC.
    Date Cleared
    1998-04-02

    (70 days)

    Product Code
    LYA
    Regulation Number
    874.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    SILIMED, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Silimed Nasal Retainer is designed for use after aesthetic and reconstructive rhinoplasty, after rhinoseptoplasty, after rhinoseptocheiloplasty and/or primary and secondary rhinocheiloplasty (cleft-lip nose patients).
    Device Description
    The Silimed Nasal Retainer was designed for prophylaxis of stenosis and cicatricial structures. It is recommended for all age groups, and for any type of nose. It has a functional format and can be sectioned by adjusting the length according to the requirement. The Silimed Nasal Retainer is composed of chemically and mechanically resistance silicone elastomer (HCRA 35M). The elastomer is soft, smooth of surface and contains a defined volume of elastomer whose shape, density and overall consistency have been chosen to replace human tissue. It has a defined length, width and circumference for the two channels that form the opening for the right and left nostril. The advantages of the Silimed Nasal Retainer are: 1) maintains the septum in a vertical position, 2) allows for nasal breathing immediately after the operation, without blocking air flow, 3) painless and non-traumatic, 4) easy to keep clean and 5) single patient use. The Silimed Nasal Retainer is available in 13 sizes. Silimed's Nasal Retainer is sterilized by ethylene oxide. The method of sterilization is shown on the package, which is a double peel pouch. An individual confirmation of each batch is carried out, as well as a quarterly confirmation by an independent laboratory.
    Ask a Question
    K Number
    K974480
    Device Name
    SILIMED CALF IMPLANT
    Manufacturer
    SILIMED, LLC.
    Date Cleared
    1998-02-24

    (90 days)

    Product Code
    MIB
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    SILIMED, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Silicone Carving Block is designed to be used in aesthetic, corrective or reconstructive surgery. The Silimod Silicone Carving Block allows the surgeon to carve a finished device for his own custom uso.
    Device Description
    Silicone Carving Blocks
    Ask a Question
    K Number
    K974482
    Device Name
    SILIMED GLUTEAL IMPLANT
    Manufacturer
    SILIMED, LLC.
    Date Cleared
    1998-02-24

    (90 days)

    Product Code
    MIB
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    SILIMED, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Silicone Carving Block is designed to be used in acsthetic, corrective or reconstructive surgery. The Silimed Silicone Carving Block allows the surgeon to carve a finished device for his own custom use.
    Device Description
    Silicone Carving Blocks
    Ask a Question

    Page 1 of 1