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510(k) Data Aggregation

    K Number
    K012070
    Device Name
    ORALLITE COMPREHENSIVE EXAM TRAY
    Manufacturer
    TRYLON CORP.
    Date Cleared
    2001-11-27

    (148 days)

    Product Code
    MPU
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    MPU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OralLite Test Kit, when used in combination with conventional visual oral mucosal in The OralLite Test Kit, when used in other used in cardification, evaluation, and examination by nealth care providers, improved facilities in the reased risk for oral cancer.
    Device Description
    Not Found
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    K Number
    K963391
    Device Name
    SPECULITE
    Manufacturer
    TRYLON CORP.
    Date Cleared
    1997-12-12

    (471 days)

    Product Code
    MPU
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    MPU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Speculoscopy is indicated for use in those women who are currently recommended for cervical screening with pelvic examination and Pap smear. - Speculoscopy is only to be used as an adjunct to the Pap smear, and only the combination of the two tests affords the clinician improved sensitivity in identifying women with mucosal abnormalities visualized on colposcopy. - The combined results of the Pap smear with Speculoscopy in the screening examination, designated Pap Plus Speculoscopy, can allow for the identification of more women who are appropriate referrals for colposcopy or close follow up than Pap smear alone.
    Device Description
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