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510(k) Data Aggregation

    K Number
    K973497
    Device Name
    HUBERLOC
    Manufacturer
    MEDCARE MEDICAL GROUP, INC.
    Date Cleared
    1998-01-13

    (120 days)

    Product Code
    LJT, MSD
    Regulation Number
    880.5965
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDCARE MEDICAL GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this device is for the removal of 90° winged infusion sets, THE GRIPPER™, and VasTack™, having a 1-1/2" needle or shorter from implanted ports and the containment of the used needle until placed in a sharps container.
    Device Description
    The MedCare Medical Group's HuberLoc is a device designed to assist in the removal and containment of Huber needles. The device consists of three plastic molded components; an inner slide and an outer housing, right and left halves. The HuberLoc is slid over the Huber needle, so the needle cannula is in the slot of the forks. Pressure is applied to the top of the HuberLoc to support the skin and the infusion port with your thumb. The first and middle finger of the same hand pull on the wings of the inner slide, in opposition to the thumb pressure. This action removes the Huber needle and draws it into the outer housing. The inner slide locks into place and contains the needle. The operation utilizes an easy one handed technique. This eliminates any rebound reflex. The HuberLoc is provided sterile, disposable, and for single patient use.
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    K Number
    K970152
    Device Name
    BIOPSY TRAY
    Manufacturer
    MEDCARE MEDICAL GROUP, INC.
    Date Cleared
    1997-03-05

    (48 days)

    Product Code
    FRG
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDCARE MEDICAL GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biopsy Tray is a single patient, single use, disposable device which is intended to conveniently provide components for the administration of biopsy procedures.
    Device Description
    The Biopsy Tray is intended to conveniently provide the auxiliary components utilized during biopsy procedures. The components are items that are commonly used during a variety of biopsy procedures. The Biopsy Tray provides the convenience of having these items packaged in a single package, sterile, and ready to use. The kits are provided sterile, disposable, and for single patient use.
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    K Number
    K962849
    Device Name
    CATHETER INSERTION TRAY
    Manufacturer
    MEDCARE MEDICAL GROUP, INC.
    Date Cleared
    1996-10-07

    (77 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDCARE MEDICAL GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Catheter Insertion Trav is a single patient, single use, disposable device which is intended to conveniently provide components to aid in the administration of percutaneous catheterization.
    Device Description
    The Catheter Insertion Tray is intended to conveniently provide the components used to aid the insertion of percutaneous catheters such as: TPN/CVP catheters, PICC Line catheters, and Long Line catheters. The Catheter Insertion Tray provides the convenience of having these commonly used items packaged in a single package, sterile, and ready to use. The kits are provided sterile, disposable, and for single patient use.
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    K Number
    K961075
    Device Name
    MEDCARE REGIONAL ANETHESIA KIT
    Manufacturer
    MEDCARE MEDICAL GROUP, INC.
    Date Cleared
    1996-09-06

    (172 days)

    Product Code
    CAZ
    Regulation Number
    868.5140
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDCARE MEDICAL GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MedCare Regional Anesthesia Kit is a single patient, single use, disposable device which is intended to be used for the administration of regional anesthesia.
    Device Description
    The MedCare Medical Group Regional Anesthesia Kit is a disposable, single patient, single use device for the administration of regional anesthesia. The componentry within the kit will vary depending on the customers requirements and the type of regional anesthesia procedure being performed; spinal, epidural-caudal, or nerve block.
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    K Number
    K962328
    Device Name
    SINGLE USE INSTRUMENT TRAY
    Manufacturer
    MEDCARE MEDICAL GROUP, INC.
    Date Cleared
    1996-08-09

    (64 days)

    Product Code
    FSM
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDCARE MEDICAL GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962527
    Device Name
    GENERAL PURPOSE DENTAL TRAY
    Manufacturer
    MEDCARE MEDICAL GROUP, INC.
    Date Cleared
    1996-08-01

    (35 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDCARE MEDICAL GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The General Purpose Dental Tray is a single patient, single use, disposable device which is intended to conveniently provide general use auxiliary components for the administration of dental procedures.
    Device Description
    The General Purpose Dental Tray is intended to conveniently provide the auxiliary components utilized during general dental procedures. The components are items that are commonly used during a variety of dental procedures. The general Purpose Dental Tray provides the convenience of having these commonly used items packaged in a single package, sterile, and ready to use. The kits are provided sterile, disposable, and for single patient use.
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    K Number
    K961880
    Device Name
    MEDCARE SUCTION CONNECTING TUBING
    Manufacturer
    MEDCARE MEDICAL GROUP, INC.
    Date Cleared
    1996-07-19

    (65 days)

    Product Code
    GCX
    Regulation Number
    880.6740
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDCARE MEDICAL GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Y ankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source).
    Device Description
    The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Yankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source). The Suction Connecting Tubing is constructed of polyvinyl chloride (PVC) plastic extruded tubing with injection molded tapered connectors solvent bonded to each end. The connectors and made of PVC and have tapered internal diameters with internal ribs
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    K Number
    K961167
    Device Name
    MEDCARE TRACHEOSTOMY CARE TRAY
    Manufacturer
    MEDCARE MEDICAL GROUP, INC.
    Date Cleared
    1996-07-02

    (99 days)

    Product Code
    LRQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDCARE MEDICAL GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MedCare Tracheostomy Care Tray is a single patient, single use, disposable device which is intended to be used for the administration of tracheostomy care.
    Device Description
    The Medcare Tracheostomy Care Tray is intended to provide the components necessary for the care and cleaning of tracheostomy tubes and their insertion sites. The procedure of tracheostomy care includes wound care of the stoma, oral/nasal/pharyngeal/tracheal suctioning, and tracheostomy tube or inner cannula cleaning or inner cannula replacement (in the case of a disposable inner cannula (D.I.C.) system). The kits are provided sterile, disposable, and for single patient use.
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