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510(k) K994321

Device
STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
Applicant
AUTOMATIC LIQUID PACKAGING, INC.
510(k) number
K994321
Product code
JOL  
Decision
Substantially Equivalent (SESE)
Decision date
2000-10-25
Date received
1999-12-22
Regulation
880.6740
Classification name
Catheter And Tip, Suction
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN BRDA
Address
2200 Lake Shore Dr. Woodstock IL US 60098 60098

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JOL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K051370STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014Baxter Healthcare Corp2005-08-12
K000265PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATIONPrimary Care Solutions, Inc.2001-07-12
K000266PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATIONPrimary Care Solutions, Inc.2001-07-12
K003402WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATIONWelcon, Inc.2001-05-01
K974758HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLEHydrox Laboratories1998-03-09
K974759HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLEHydrox Laboratories1998-03-09
K974397STERILE SALINE FOR CATHETER CAREBaxter Healthcare Corp1998-02-10
K973734STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATIONWelcon, Inc.1998-02-05
K972372GERM TRAPPER SUCTION TUBE HOLDERRzv Medical Specialties, Inc.1997-12-11
K960216CPR SUCTION CATHETER KITCustom Pack Reliability1996-04-15
K954442STERILE ISOTONIC SALINE & STERILE WATERMedcare Custom Packaging, Inc.1995-12-21
K950201ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETERSherwood Medical Co.1995-12-15
K951524THORACENTESIS CATHETERBaxter Healthcare Corp1995-07-06
K945728CATCO THORACIC CATHETERCatco Medical, Inc.1995-05-23
K943661STERILE PHYSIOLOGICAL SALINE/STERILE WATERMedcare Custom Packaging, Inc.1995-04-10

Legacy Summary#

summary

FDA Review#

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