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Found 7 results

510(k) Data Aggregation

    K Number
    K972227
    Device Name
    SHOE COVER
    Manufacturer
    AMERICAN SEAL CO.
    Date Cleared
    1997-09-09

    (88 days)

    Product Code
    FYF
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    FYF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Shoe Cover is a device intended to be worn by hospital personnel from transfer of procedures to protect both the patient and the hospital personnel from transfer of materials.
    Device Description
    Shoe Cover
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    K Number
    K955833
    Device Name
    NIOMED SURGICAL CAPS
    Manufacturer
    AMERASIA CORP.
    Date Cleared
    1996-03-15

    (80 days)

    Product Code
    FYF
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    FYF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K954556
    Device Name
    SURGICAL CAP
    Manufacturer
    THAI DISPOSABLE PRODUCTS CO., LTD.
    Date Cleared
    1996-03-12

    (162 days)

    Product Code
    FYF
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    FYF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K954454
    Device Name
    NIOMED SURGICAL HOOD
    Manufacturer
    AMERASIA CORP.
    Date Cleared
    1996-01-23

    (120 days)

    Product Code
    FYF
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    FYF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K954455
    Device Name
    NIOMED BOUFFANT CAPS
    Manufacturer
    AMERASIA CORP.
    Date Cleared
    1996-01-23

    (120 days)

    Product Code
    FYF
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    FYF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K953878
    Device Name
    BOUFFANT CAP
    Manufacturer
    AMERICAN THRESHOLD INDUSTRIES, INC.
    Date Cleared
    1996-01-05

    (142 days)

    Product Code
    FYF
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    FYF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K953879
    Device Name
    SURGEON'S CAP
    Manufacturer
    AMERICAN THRESHOLD INDUSTRIES, INC.
    Date Cleared
    1996-01-05

    (142 days)

    Product Code
    FYF
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    FYF

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

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