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510(k) Data Aggregation

    K Number
    K992926
    Device Name
    GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195)
    Manufacturer
    RI MOS. S.R.L.
    Date Cleared
    1999-10-26

    (56 days)

    Product Code
    HHK
    Regulation Number
    884.1175
    Why did this record match?
    Applicant Name (Manufacturer) :

    RI MOS. S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For endometrial sampling for histologic biopsy of the uterine mucosal lining including post menopausal patients.
    Device Description
    The RI. MOS. s.r.l. curette operates manually by applied vacuum suction and is a sterile single-use disposable device.
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    K Number
    K991895
    Device Name
    RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217)
    Manufacturer
    RI MOS. S.R.L.
    Date Cleared
    1999-08-12

    (70 days)

    Product Code
    HHK
    Regulation Number
    884.1175
    Why did this record match?
    Applicant Name (Manufacturer) :

    RI MOS. S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For endometrial sampling for histologic biopsy of the uterine mucosal lining.
    Device Description
    The RI.MOS. s.r.l. curette operates by negative pressure and is a sterile, single-use, disposable device.
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    K Number
    K991827
    Device Name
    GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043
    Manufacturer
    RI MOS. S.R.L.
    Date Cleared
    1999-07-19

    (52 days)

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

    RI MOS. S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RI MOS. s.r.l. Cuscovag, Specuvag and Specuvag AS devices are used to expose the interior of the vagina. The Cuscovag is indicated as an aid for routine examination in adolescent and geriatric women, the Specuvag as an aid for routine examination and the Specuvag AS as an aid for routine examination and procedures where smoke must be evacuated from the vaginal canal.
    Device Description
    The RI. MOS. s.r.l. speculae line are sterile, single-use, disposable devices.
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    K Number
    K983897
    Device Name
    CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G
    Manufacturer
    RI MOS. S.R.L.
    Date Cleared
    1999-02-01

    (90 days)

    Product Code
    HEE
    Regulation Number
    884.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    RI MOS. S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RI. MOS. Cervical and Intracervical Anaesthesia Needles are used to apply cervical and intracervical anesthesia block.
    Device Description
    The RI. MOS. s.r.l. cervical and intracervical needles operate with standard medical syringes are are sterile, single-use, disposable devices.
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