FDA 510(k) Applications for Medical Device Product Code "JOL"
(Catheter And Tip, Suction)

FDA 510(k) Number Applicant Device Name Decision Date
K994321 AUTOMATIC LIQUID PACKAGING, INC. STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP 10/25/2000
K974397 BAXTER HEALTHCARE CORP. STERILE SALINE FOR CATHETER CARE 02/10/1998
K051370 BAXTER HEALTHCARE CORP. STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 08/12/2005
K960216 CUSTOM PACK RELIABILITY CPR SUCTION CATHETER KIT 04/15/1996
K974759 HYDROX LABORATORIES HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE 03/09/1998
K974758 HYDROX LABORATORIES HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE 03/09/1998
K000266 PRIMARY CARE SOLUTIONS, INC. PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION 07/12/2001
K000265 PRIMARY CARE SOLUTIONS, INC. PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION 07/12/2001
K972372 RZV MEDICAL SPECIALTIES, INC. GERM TRAPPER SUCTION TUBE HOLDER 12/11/1997
K973734 WELCON, INC. STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION 02/05/1998
K003402 WELCON, INC. WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION 05/01/2001


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