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510(k) Data Aggregation

    K Number
    K000388
    Date Cleared
    2000-08-08

    (183 days)

    Product Code
    Regulation Number
    876.5220
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLEARWATER COLON HYDROTHERAPY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K942867
    Date Cleared
    1996-06-26

    (740 days)

    Product Code
    Regulation Number
    876.5220
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLEARWATER COLON HYDROTHERAPY, INC.

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

    Ask a specific question about this device

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