FDA 510(k) Applications for Medical Device Product Code "KHJ"
(Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material))

FDA 510(k) Number Applicant Device Name Decision Date
K013243 BIOFORM, INC. COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1 01/09/2002
K060561 CAMBRIDGEMED CLEARADEX GEL 05/30/2006
K070093 CEREMED INC. OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE 01/24/2007
K122561 CEREMED, INC. ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN 11/27/2012
K120220 CEREMED, INC. ADAPTAIN SOLUBLE IMPLANT MATERIAL 06/06/2012
K132198 CEREMED, INC. ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI 09/12/2013
K081531 CEREMED, INC. AOC SOLUBLE IMPLANT MATERIAL 07/18/2008
K082245 CEREMED, INC. AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV 09/18/2008
K103047 CEREMED, INC. CERETENE SOLUBLE IMPLANT MATERIAL 01/05/2011
K062280 CEREMED, INC. OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE 12/11/2006
K161000 COOK BIOTECH INCORPORATED Biodesign Otologic Repair Graft 05/11/2016
K121360 COOK BIOTECH INCORPRATED BIODESIGN ENT REPAIR GRAFT 02/27/2013
K150594 COOK BIOTECH INCORPRATED Biodesign Otologic Repair Graft 09/16/2015
K051911 CURAMEDICAL, BV GELITA-SPON 12/06/2005
K060878 CURAMEDICAL, BV GELITA-SPON ABSORBABLE GELATIN SPONGE, USP 04/13/2006
K051487 DOCTOR'S RESEARCH GROUP, INC. DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE 12/22/2005
K972700 EXMOOR PLASTICS LTD. EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN) 07/16/1998
K003855 FIDIA ADVANCED BIOPOLYMERS SRL HYALOMATRIX CO 07/03/2001
K043035 GENZYME CORPORATION SEPRAGEL ENT BIORESORBABLE PACKING/STENT 07/11/2005
K974311 GYRUS ENT L.L.C. VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT 03/04/1998
K991324 HEINZ KURZ TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE) 05/18/1999
K033796 HEINZ KURZ GMBH MEDIZINTECHNIK KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS 01/30/2004
K002972 MEDTRONIC XOMED MEROGEL CONTROL GEL ENT SURGICAL DRESSING 12/15/2000
K080022 VASCULAR SOLUTIONS, INC. GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP 12/09/2008
K982870 XOMED, INC. EPIFILM OTOLOGIC LAMINA 11/03/1998
K964484 XOMED, INC. KARTUSH TM PATCHER 01/24/1997
K001148 XOMED, INC. MEROGEL OTOLOGIC PACK 06/03/2000
K970910 XOMED, INC. XOMED SILICONE BLOCK/STRIP 05/02/1997
K982294 XOMED, INC. XOMED SILICONE PRE-FORM BLOCKS 09/18/1998


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