LogoFDA 510(k) Search
Search Filters

Search Results

Found 8 results

510(k) Data Aggregation

    K Number
    K002071
    Device Name
    SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Date Cleared
    2000-07-24

    (17 days)

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

    TISSUE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000849
    Device Name
    SOFTFORM FACIAL IMPLANT
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Date Cleared
    2000-05-19

    (65 days)

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

    TISSUE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K982475
    Device Name
    SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Date Cleared
    1998-09-22

    (68 days)

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

    TISSUE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For Plastic and Reconstructive Surgery* * This product is available by prescription only.
    Device Description
    Softform® Implant Soft Tissuc Augmentation Tube with Insertion Tool - Size Modifications
    Ask a Question
    K Number
    K973462
    Device Name
    SOFTFORM FACIAL IMPLANT
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Date Cleared
    1997-11-24

    (73 days)

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

    TISSUE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For Plastic and Reconstructive Surgery*
    Device Description
    SoftForm™ Implant
    Ask a Question
    K Number
    K970804
    Device Name
    TRU-PULSE CO2 SURGICAL LASER
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Date Cleared
    1997-06-03

    (91 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    TISSUE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Coagulation, vaporization, ablation, or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.
    Device Description
    Tru-Pulse™ Pulsed CO2 Surgical laser is an Rf excited gas-slab pulsed CO2 laser which produces 1-10 watts average power
    Ask a Question
    K Number
    K963683
    Device Name
    TRU-PULSE LASER (MODIFIED)
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Date Cleared
    1997-02-12

    (167 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    TISSUE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K962496
    Device Name
    SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.)
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Date Cleared
    1996-09-03

    (69 days)

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

    TISSUE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K960481
    Device Name
    SOFT TISSUE AUGMENTATION TUBE
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Date Cleared
    1996-04-01

    (59 days)

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

    TISSUE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1