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510(k) Data Aggregation

    K Number
    K992522
    Device Name
    SPECTRUM DESIGNS SPECTRAGEL
    Manufacturer
    SPECTRUM DESIGNS, INC.
    Date Cleared
    1999-10-26

    (90 days)

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

    SPECTRUM DESIGNS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Spectrum Designs Spectragel is indicated for use in the topical mangement of hypertrophic and keloid scars. Spectrum Designs Spectragel may also be used prophylactically to help retard the formation of such scars.
    Device Description
    Spectragel is used only on intact skin and is manufactured out of medical grade, biocompatible silicone material.
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    K Number
    K982688
    Device Name
    SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK
    Manufacturer
    SPECTRUM DESIGNS, INC.
    Date Cleared
    1998-10-13

    (71 days)

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

    SPECTRUM DESIGNS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spectrum Designs Pre-Form Contour Silicone Carving Block is a pre-formed solid silicone block, to be used where a shaped, cut-to-fit implant is desired. It is designed for use in augmenting or reconstructing cartilaginous tissue, soft tissue and bone. The preshaped aspect of the implant allows the surgeon increased options when cutting or shaping the implant to the size and shape demanded by a specific surgical situation.
    Device Description
    The Spectrum Designs Pre-Form Contour Silicone Carving Block Implant is fabricated from solid silicone elastomer and has an inherent, pre-formed, rounded shape.
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    K Number
    K980444
    Device Name
    SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT
    Manufacturer
    SPECTRUM DESIGNS, INC.
    Date Cleared
    1998-05-06

    (90 days)

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

    SPECTRUM DESIGNS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spectrum Designs Bilateral Groove Chin Implant is intended to augment or reconstruct congenital or traumatic chin deficiencies.
    Device Description
    The Spectrum Designs Bilateral Chin Implant is manufactured from medical grade solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton. It is provided non-sterile and available in six sizes.
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    K Number
    K980445
    Device Name
    SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT
    Manufacturer
    SPECTRUM DESIGNS, INC.
    Date Cleared
    1998-05-06

    (90 days)

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

    SPECTRUM DESIGNS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spectrum Designs Concave Back Chin Implant is intended to augment or reconstruct congenital or traumatic chin deficiencies.
    Device Description
    The Spectrum Designs Concave Back Chin Implant is manufactured from medical grade solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton. It is provided non-sterile and available in six sizes.
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    K Number
    K980446
    Device Name
    SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT
    Manufacturer
    SPECTRUM DESIGNS, INC.
    Date Cleared
    1998-05-06

    (90 days)

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

    SPECTRUM DESIGNS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spectrum Designs Anterior Chin Implant is intended to augment or reconstruct congenital or traumatic chin deficiencies.
    Device Description
    The Spectrum Designs Anterior Chin Implant is manufactured from medical grade solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton. It is provided non-sterile and available in six sizes.
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    K Number
    K980462
    Device Name
    SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT
    Manufacturer
    SPECTRUM DESIGNS, INC.
    Date Cleared
    1998-05-06

    (90 days)

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

    SPECTRUM DESIGNS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spectrum Designs Anatomical Chin Implant is intended to augment or reconstruct congenital or traumatic chin deficiencies.
    Device Description
    The Spectrum Designs Anatomical Chin Implant is manufactured from medical grade solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton. It is provided non-sterile and available in two sizes.
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    K Number
    K980463
    Device Name
    SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT
    Manufacturer
    SPECTRUM DESIGNS, INC.
    Date Cleared
    1998-05-06

    (90 days)

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

    SPECTRUM DESIGNS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spectrum Designs Curvilinear Chin Implant is a silicone facial implant, designed to augment or reconstruct the mandibular or chin area of the face.
    Device Description
    The Spectrum Designs Curvilinear Chin Implant is manufactured from medical grade solid silicone elastomer. It is provided non-sterile and available in three sizes.
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    K Number
    K980138
    Device Name
    SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT
    Manufacturer
    SPECTRUM DESIGNS, INC.
    Date Cleared
    1998-04-03

    (78 days)

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

    SPECTRUM DESIGNS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spectrum Designs Symmetrical Chin Implant is intended to augment or reconstruct the mandibular or chin area of the face.
    Device Description
    Spectrum Designs Symmetrical Chin Implant is manufactured from solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton.
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    K Number
    K980461
    Device Name
    SPECTRUM DESIGNS CLEFT CHIN IMPLANT
    Manufacturer
    SPECTRUM DESIGNS, INC.
    Date Cleared
    1998-03-04

    (27 days)

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

    SPECTRUM DESIGNS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spectrum Designs Cleft Chin Implant is intended to augment or reconstruct the mandibular or chin area of the face.
    Device Description
    The Spectrum Designs Cleft Chin Implant is manufactured from solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton.
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    K Number
    K980139
    Device Name
    SPECTRUM DESIGNS PROFILE MALAR IMPLANT
    Manufacturer
    SPECTRUM DESIGNS, INC.
    Date Cleared
    1998-03-03

    (47 days)

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

    SPECTRUM DESIGNS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spectrum Designs Profile Malar Implant is intended to augment or reconstruct the malar region of the face.
    Device Description
    Spectrum Designs Profile Malar Implant is manufactured from solid silicone elastomer. The implant is implanted in a pocket created by the surgeon in the malar-zygomatic region of the facial skeleton to augment the existing facial structure.
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