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510(k) Data Aggregation

    K Number
    K994321
    Device Name
    STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
    Manufacturer
    AUTOMATIC LIQUID PACKAGING, INC.
    Date Cleared
    2000-10-25

    (308 days)

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

    AUTOMATIC LIQUID PACKAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sterile Water and Saline Solutions are defined as an accessory to a device that is intended For Device Cleaning and Irrigation.
    Device Description
    Automated Liquid Packaging, Inc. Sterile Water and Saline Solutions are products that have been used in the medical community for decades. The only ingredient in the two solutions other than water is Sodium Chloride; there are no preservatives or stabilizers. The irrigation bottle is manufactured of 100% low density polyethylene (LDPE) and contains no color or chemical additives. The two solutions are sterile, aseptically filled and are hermetically sealed for single use only.
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    K Number
    K000964
    Device Name
    STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109
    Manufacturer
    AUTOMATIC LIQUID PACKAGING, INC.
    Date Cleared
    2000-04-25

    (29 days)

    Product Code
    JOH
    Regulation Number
    868.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUTOMATIC LIQUID PACKAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K980147
    Device Name
    YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION
    Manufacturer
    AUTOMATIC LIQUID PACKAGING, INC.
    Date Cleared
    1998-04-13

    (88 days)

    Product Code
    LPN
    Regulation Number
    886.5928
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUTOMATIC LIQUID PACKAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    STORE NAME Multi-Purpose Solution is indicated for use in cleaning, chemical (NOT HEAT) disinfection, and storing of soft (hydrophilic) contact leases.
    Device Description
    A sterile isotatic, phosphate buffered saline solution containing polyoxyethylens polyoxypropylene block copolymer, preserved with 0.128% EDTA and 0.0001% Cosmocil CQ (polyhexamethylene biguanide). Contains no chiorhaxidine or thimerosal. Cleans, loosens and removes accurations of films, deposits and dabris from soft consist. Innissa, Destroys harmful microorganisms on the surface of the lens. Rinses, stores and rewels lenses before the lansas are placed on the eye.
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    K Number
    K973829
    Device Name
    IRRIGATION BOTTLE
    Manufacturer
    AUTOMATIC LIQUID PACKAGING, INC.
    Date Cleared
    1998-02-23

    (139 days)

    Product Code
    JOH, DAT
    Regulation Number
    868.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUTOMATIC LIQUID PACKAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This solution is indicated for use as a tracheal lavage, nasal irrigation solution or as an irrigation solution for flushing a body cavity.
    Device Description
    Automatic Liquid Packaging, Inc. Sterile Water and Saline Solutions are products that have been used in the medical community for decades. These products have not experienced or been associated with toxic or undesirable effects that relate to the ingredients used in their production. The only ingredient in the two solutions other than water is Sodium Chloride; there are no preservatives or stabilizers. The irrigation bottle is manufactured of 100% virgin low density polyethylene (LDPE) and contains no regrind, color or chemical additives. The two solutions are sterile, aseptically filled, and are hermetically sealed for Single Use Only.
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    K Number
    K962079
    Device Name
    HUMIDIFIER ADAPTER
    Manufacturer
    AUTOMATIC LIQUID PACKAGING, INC.
    Date Cleared
    1996-07-31

    (64 days)

    Product Code
    BTT
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUTOMATIC LIQUID PACKAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955104
    Device Name
    HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER
    Manufacturer
    AUTOMATIC LIQUID PACKAGING, INC.
    Date Cleared
    1996-06-11

    (216 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUTOMATIC LIQUID PACKAGING, INC.

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

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