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510(k) Data Aggregation

    K Number
    K991593
    Device Name
    ORIBRUSH - STANDARD - B002
    Manufacturer
    Date Cleared
    1999-06-29

    (53 days)

    Product Code
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORIFICE MEDICAL AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ENDOCERVICAL CYTOLOGICAL CELL COLLECTOR BRUSH FOR PAP SMEAR.
    Device Description
    Not Found
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    K Number
    K991595
    Device Name
    ORIBRUSH - WITH PROTECTIVE TIP - B001
    Manufacturer
    Date Cleared
    1999-06-29

    (53 days)

    Product Code
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORIFICE MEDICAL AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ENDOCERVICAL CYTOLOGICAL CELL COLLECTOR BRUSH FOR PAP SMEAR.
    Device Description
    ORIBRUSH - WITH PROTECTIVE TIP - B001
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    Ask a specific question about this device

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