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510(k) Data Aggregation

    K Number
    K013321
    Device Name
    SILICONE TRACHEAL T-TUBES
    Manufacturer
    TECHNICAL PRODUCTS, INC.
    Date Cleared
    2002-06-04

    (242 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHNICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. As a stent to aid in the rehabilitation of tracheal stenosis 2. As a stent to temporarily aid in laryngotracheal injuries 3. To support a Reconstituted Trachea 4. As a stent to provide an airway for a cervical trachea that cannot be repaired
    Device Description
    Not Found
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    K Number
    K973385
    Device Name
    OVAL SHAPES
    Manufacturer
    TECHNICAL PRODUCTS, INC.
    Date Cleared
    1997-12-05

    (88 days)

    Product Code
    HXA
    Regulation Number
    888.3025
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHNICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The purchaser shall sufficiently inform themselves regarding the use of silicone materials in any surgical procedure to insure its proper use. Sil-Tec Medical Grade Oval Shape is a soft, radiopaque silicon elastomer shape intended for reconstruction and surgical repair procedures. Some uses have been: As temporary stents for the formation of new tendon sheaths. Other surgical repair procedures demanding a highly inert and flexible oval shaped material.
    Device Description
    Sil-Tec Medical Grade Oval Shape is a soft, radiopaque silicon elastomer shape intended for reconstruction and surgical repair procedures.
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    K Number
    K973166
    Device Name
    DOW CORNING SILASTIC ELASTOMER Q7-4750
    Manufacturer
    TECHNICAL PRODUCTS, INC.
    Date Cleared
    1997-11-21

    (88 days)

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

    TECHNICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sil-Tec Medical Grade rod is a soft, translucent silicon elastomer rod intended for reconstruction and surgical repair procedures. The rod is made in two grades of material: 1. The short term rods carry a catalog number with a suffix ST for short term procedures requiring implantation for less than 30 days. 2. The long term rods carry a catalog number with a suffix LT for implantation procedures requiring longer than 30 days. Some uses have been: 1. As temporary stents for the formation of new tendon sheaths 2. Other surgical repair procedures demanding a highly inert and flexible rod shaped material
    Device Description
    Sil-Tec Medical Grade rod is a soft, translucent silicon elastomer rod intended for reconstruction and surgical repair procedures. The rod is made in two grades of material: 1. The short term rods carry a catalog number with a suffix ST for short term procedures requiring implantation for less than 30 days. 2. The long term rods carry a catalog number with a suffix LT for implantation procedures requiring longer than 30 days.
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    K Number
    K971472
    Device Name
    SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA
    Manufacturer
    TECHNICAL PRODUCTS, INC.
    Date Cleared
    1997-07-01

    (69 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHNICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sil Tec Medical Grade Silicone Sheeting is suitable for external use or short-term mplantanon (30 days or less). Sil-Tec sheeting is intended for modification with a scalpel or scissors, by the surgeon or medical practical practions patientspecific applicanons. Patient selection and suitability is up to the surgeon/medical practioner user The surgeon/medical practitioner user must rely on his or her own best medical judgment and training as to the use of this device. The following are some indications where silicone sheeting bas been successfully employed Surgical repairs, anchoring device for hemodialysis shunts; temporary covering for a presentally ruptured omphalocele during staged repair of wethral strictures; protective to help facilitate neural regeneration and tendon healing, surgical repair of fractured orbital floors; to prevent soft tissue fibrosis or bony michlosis following surgical correction of trismus (Waming Note: Not for permanent use in the presence of degenerative bone changes, chronic bruxism, or temporomandibular 1011 applications); other surgical procedures; and as insulating material for recoveramulation. It is the surgeon/medical practitioner users responsibility to thoroughly test any products made in part or otherwise incorporating Sil-Tec medical grade sheeting to determine the acceptability of the products performance in a specific application.
    Device Description
    Sil-Tec Sheeting
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    K Number
    K971613
    Device Name
    SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING
    Manufacturer
    TECHNICAL PRODUCTS, INC.
    Date Cleared
    1997-05-22

    (20 days)

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

    TECHNICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The purchaser should thoroughly test products made in part or otherwise incorporating Sil-Tec medical grade tubing to determine the acceptability of the products performance in a specific application Applications for Tubing include : - Stillcone tubing has been used in artificial external or l .. internal blood circulatory systems where temporary substitution is needed for the heart, lungs, and arieriovenous system - 2 Blood transfusions - Suction drainage of surgical wounds 3 - Temporary tube gastrostomy following abdominal surgery 4 - Connecting glass tubing of different bores 5
    Device Description
    Sil-Tec Medical Grade Tubing
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