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KMJ — Lubricant, Patient Class I

FDA Device Classification

Classification Details

Product Code
KMJ
Device Class
Class I
Regulation Number
880.6375
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K142473sion biotext medicalLubricating JellyApril 13, 2015
K141028pediatric pharmaceuticalsCOLONGLIDE LUBRICANTJuly 24, 2014
K131617pediatric pharmaceuticalsCOLONGLIDE(R) LUBRICANTOctober 3, 2013
K121390nurse assistLUBE JELLY SURINGEAugust 10, 2012
K113689dukal corporationDUKAL LUBRICATING JELLYMay 4, 2012
K112110jianerkang medical dressingSTERILE LUBRICATING JELLYApril 10, 2012
K103718medline industriesDYNACOR LUBRICATION GELMay 10, 2011
K101522ultra seal corporationULTRA SEAL STERILE LUBRICATING JELLYDecember 23, 2010
K092488dynarex corporationDYNAREX STERILE LUBRICATING JELLYDecember 18, 2009
K083189avail medical productsSTERI-LUB LUBRICATION GELNovember 21, 2008
K073684sheffield industries, div. of fariaSHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGELMay 22, 2008
K080042spirus medicalSPIRUS MEDICAL SURGICAL INSTRUMENTApril 3, 2008
K042563ssl americasDUREX PLAY WARMER LUBRICANTFebruary 23, 2005
K041060chester labsE-Z LUBRICATING JELLYMay 7, 2004
K020586biofilmGOOD LUBRICATIONSJanuary 24, 2003
K974768nice-pak productsPDI STERILE LUBRICATING JELLYJanuary 16, 1998
K973557qualisLUBRIGLIDEOctober 10, 1997
K961502span-america medical systemsLUBRICATING JELLY, LOW VISCOSITYJuly 18, 1996
K961222pharmaceutical innovationsEVRON GELJune 26, 1996
K951431depuy healthcareAQUAGEL LUBRICATING JELLYJuly 21, 1995