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510(k) Data Aggregation

    K Number
    K050112
    Device Name
    PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117
    Manufacturer
    PRIME PACIFIC HEALTH INNOVATIONS CORPORATION
    Date Cleared
    2005-03-15

    (56 days)

    Product Code
    KPL
    Regulation Number
    876.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRIME PACIFIC HEALTH INNOVATIONS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indication for use of this device must be restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.
    Device Description
    The Pro-Fit™ disposable rectal speculum is a non-metal (Polyethelene) device used to introduce water into the colon and dispose waste from the colon during a colonic irrigation procedure.
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    K Number
    K000031
    Device Name
    AQUANET, MODEL EC 2000
    Manufacturer
    PRIME PACIFIC HEALTH INNOVATIONS CORPORATION
    Date Cleared
    2001-09-10

    (614 days)

    Product Code
    KPL
    Regulation Number
    876.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRIME PACIFIC HEALTH INNOVATIONS CORPORATION

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

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