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510(k) Data Aggregation

    K Number
    K974068
    Device Name
    PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL
    Manufacturer
    TECNOL MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-12-22

    (55 days)

    Product Code
    MSH
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECNOL MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PFR95TM Particulate Filter Respirator and Surgical Masks are intended for use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.
    Device Description
    Respirator consisting of nonwoven inter facing, filter media(s), and an outer facing. It covers the nose and mouth of the wearer, and is held in place with two synthetic elastic headbands, conforming to the curvature of the wearer's nose with a malleable nosepiece.
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    K Number
    K970448
    Device Name
    PCM 2000; ISOLAIR APR MODEL 2735
    Manufacturer
    TECNOL MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-04-30

    (83 days)

    Product Code
    MSH
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECNOL MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Meets the CDC guidelines for TB exposure control. Has a filter efficiency level of 95% against solid particulate aerosols free of oil (Type N95 respirator). Designed to be fluid resistant to splash and spatter of blood and body fluids.
    Device Description
    Respirator consisting of nonwoven inter facing, filter media(s), a fluid barrier film, and an outer facing. It covers the nose and mouth of the wearer, and is held in place with two synthetic clastic headbands, conforming to the curvature of the wearer's nose with a malleable nosepiece.
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    K Number
    K963552
    Device Name
    QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350)
    Manufacturer
    TECNOL MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-11-22

    (78 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECNOL MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K963559
    Device Name
    WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010)
    Manufacturer
    TECNOL MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-11-22

    (78 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECNOL MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963564
    Device Name
    PERSONAL LIMB HOLDER (24444-200,300,24444-KIT)
    Manufacturer
    TECNOL MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-11-22

    (78 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECNOL MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963554
    Device Name
    24448-010 SECURE-ALL FINGER CONTROL MITT
    Manufacturer
    TECNOL MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-11-21

    (77 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECNOL MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963556
    Device Name
    SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030)
    Manufacturer
    TECNOL MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-11-21

    (77 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECNOL MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963557
    Device Name
    SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030
    Manufacturer
    TECNOL MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-11-21

    (77 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECNOL MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963561
    Device Name
    ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040)
    Manufacturer
    TECNOL MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-11-21

    (77 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECNOL MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963563
    Device Name
    ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145)
    Manufacturer
    TECNOL MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-11-21

    (77 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECNOL MEDICAL PRODUCTS, INC.

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

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