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510(k) Data Aggregation

    K Number
    K971988
    Device Name
    ALLEN, ULTRA AND SMART SOCKETS
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Date Cleared
    1997-07-11

    (43 days)

    Product Code
    FQO, FWW, GDC
    Regulation Number
    878.4960
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLEN MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Devices are intended to attach boot stirrups to operating revm table rail or cysto table rail during surgical or diagnostic procedures requiring positioning and support of the patient's legs.
    Device Description
    Not Found
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    K Number
    K964273
    Device Name
    DURA-BOARD ARMBOARD
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Date Cleared
    1997-01-08

    (72 days)

    Product Code
    GDC, FQO, FWW
    Regulation Number
    878.4960
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLEN MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K960027
    Device Name
    HIGH VOLUME I.V. & IRRIGATION TOWER
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Date Cleared
    1996-03-12

    (70 days)

    Product Code
    FOX
    Regulation Number
    880.6990
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLEN MEDICAL SYSTEMS, INC.

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

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