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Found 6 results
510(k) Data Aggregation
K Number
K994321Device 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
880.6740Why 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
K000964Device 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
868.5800Why 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
K980147Device 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
886.5928Why 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
K973829Device Name
IRRIGATION BOTTLE
Manufacturer
AUTOMATIC LIQUID PACKAGING, INC.
Date Cleared
1998-02-23
(139 days)
Product Code
JOH, DAT
Regulation Number
868.5800Why 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
K962079Device Name
HUMIDIFIER ADAPTER
Manufacturer
AUTOMATIC LIQUID PACKAGING, INC.
Date Cleared
1996-07-31
(64 days)
Product Code
BTT
Regulation Number
868.5450Why 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
K955104Device Name
HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER
Manufacturer
AUTOMATIC LIQUID PACKAGING, INC.
Date Cleared
1996-06-11
(216 days)
Product Code
CAF
Regulation Number
868.5630Why 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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