FDA 510(k) Applications for Medical Device Product Code: KMJ (Lubricant, Patient)

FDA 510(k) Applications for Medical Device Product Code "KMJ"
(Lubricant, Patient)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K083189	AVAIL MEDICAL PRODUCTS, INC.	STERI-LUB LUBRICATION GEL	11/21/2008
K020586	BIOFILM, INC.	GOOD LUBRICATIONS	01/24/2003
K041060	CHESTER LABS, INC.	E-Z LUBRICATING JELLY	05/07/2004
K113689	DUKAL CORPORATION	DUKAL LUBRICATING JELLY	05/04/2012
K092488	DYNAREX CORPORATION	DYNAREX STERILE LUBRICATING JELLY	12/18/2009
K112110	JIANERKANG MEDICAL DRESSING COMPANY	STERILE LUBRICATING JELLY	04/10/2012
K103718	MEDLINE INDUSTRIES, INC.	DYNACOR LUBRICATION GEL	05/10/2011
K974768	NICE-PAK PRODUCTS, INC.	PDI STERILE LUBRICATING JELLY	01/16/1998
K121390	NURSE ASSIST, INC.	LUBE JELLY SURINGE	08/10/2012
K141028	PEDIATRIC PHARMACEUTICALS INC.	COLONGLIDE LUBRICANT	07/24/2014
K131617	PEDIATRIC PHARMACEUTICALS, INC.	COLONGLIDE(R) LUBRICANT	10/03/2013
K961222	PHARMACEUTICAL INNOVATIONS, INC.	EVRON GEL	06/26/1996
K973557	QUALIS, INC.	LUBRIGLIDE	10/10/1997
K073684	SHEFFIELD INDUSTRIES, DIV. OF FARIA LTD.	SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL	05/22/2008
K142473	SION BIOTEXT MEDICAL LTD	Lubricating Jelly	04/13/2015
K961502	SPAN-AMERICA MEDICAL SYSTEMS, INC.	LUBRICATING JELLY, LOW VISCOSITY	07/18/1996
K080042	SPIRUS MEDICAL, INC.	SPIRUS MEDICAL SURGICAL INSTRUMENT	04/03/2008
K042563	SSL AMERICAS, INC.	DUREX PLAY WARMER LUBRICANT	02/23/2005
K101522	ULTRA SEAL CORPORATION	ULTRA SEAL STERILE LUBRICATING JELLY	12/23/2010