LogoFDA 510(k) Search
Search Filters

Search Results

Found 7 results

510(k) Data Aggregation

    K Number
    K013732
    Device Name
    GELZONE
    Manufacturer
    IMPLANTECH ASSOCIATES, INC.
    Date Cleared
    2002-02-07

    (90 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMPLANTECH ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Gelzone is indicated for use in the management of keloid and hypertrophic scars. Gelzone may also be used prophylactically to help retard the formation of such scars.
    Device Description
    Gelzone is a soft, semi-occlusive, slightly adhesive silicone gel backed by a polyester hook and loop fabric.
    Ask a Question
    K Number
    K012419
    Device Name
    CONFORM SHEETING, MODEL IGEL
    Manufacturer
    IMPLANTECH ASSOCIATES, INC.
    Date Cleared
    2001-10-24

    (86 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMPLANTECH ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Conform Sheeting is indicated for use in the management of keloid and hypertrophic Scars. Conform Sheeting may also be used prophylactically to help retard the formation of such scars.
    Device Description
    Not Found
    Ask a Question
    K Number
    K002886
    Device Name
    IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
    Manufacturer
    IMPLANTECH ASSOCIATES, INC.
    Date Cleared
    2000-11-24

    (70 days)

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

    IMPLANTECH ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K973502
    Device Name
    IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT
    Manufacturer
    IMPLANTECH ASSOCIATES, INC.
    Date Cleared
    1997-11-07

    (52 days)

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

    IMPLANTECH ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Implantech Conform™ Combined Submalar® Implant is indicated for implantation to augment or reconstruct the underdeveloped or traumatized malar region of the face. The soft, flexible Conform Combined Submalar Implant is designed to easily conform to the facial skeleton in the malar area.
    Device Description
    The soft, flexible Conform Combined Submalar Implant is designed to easily conform to the facial skeleton in the malar area.
    Ask a Question
    K Number
    K964846
    Device Name
    IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING
    Manufacturer
    IMPLANTECH ASSOCIATES, INC.
    Date Cleared
    1997-02-12

    (71 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMPLANTECH ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K962824
    Device Name
    IMPLANTECH JEJ PERI-PYRIFORM IMPLANT
    Manufacturer
    IMPLANTECH ASSOCIATES, INC.
    Date Cleared
    1996-10-03

    (76 days)

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

    IMPLANTECH ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K962261
    Device Name
    IMPLANTECH WM NASAL-LABIAL IMPLANT
    Manufacturer
    IMPLANTECH ASSOCIATES, INC.
    Date Cleared
    1996-08-19

    (68 days)

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

    IMPLANTECH ASSOCIATES, INC.

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

    Page 1 of 1