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510(k) Data Aggregation

    K Number
    K003744
    Device Name
    ENRAF-NONIUS ENDOMED 182 SYSTEM
    Manufacturer
    HENLEY HEALTHCARE, INC.
    Date Cleared
    2002-02-20

    (443 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    HENLEY HEALTHCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000084
    Device Name
    ENRAF-NONIUS SONOPULS 190 SYSTEM
    Manufacturer
    HENLEY HEALTHCARE, INC.
    Date Cleared
    2000-08-04

    (205 days)

    Product Code
    IMI
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    HENLEY HEALTHCARE, INC.

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

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