FDA 510(k) Applications for Medical Device Product Code "KKO"
(Ring, Teething, Fluid-Filled)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K091198 | ALLIED HILL ENTERPRISES, LTD. | LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING | 12/07/2009 |
| K014023 | ANGELINA TRADING, INC. | BABY TEETHER, MODEL 20104 | 08/02/2002 |
| K013587 | BABIES BEST, INC. | BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS | 05/14/2002 |
| K110615 | BEBE TOYS MANUFACTORY LTD. | WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE | 12/02/2011 |
| K072082 | BIOMEDEVICE LTD. | GUMEASE DENTAL MOUTHPIECE | 11/05/2007 |
| K965082 | CONSOLIDATED STORES CORP. | SOOTHING WATER-FILLED TEETHER | 03/11/1997 |
| K002066 | COOL BABY, INC. | FREEZER TEETHER | 09/26/2000 |
| K981202 | CORIUM CORP. | WATER FILLED GUM SOOTHER | 06/16/1998 |
| K052513 | DELTA ENTERPRISE CORPORATION | BABY SNOOPY WATER FILLED TEETHER, MODEL 95367 | 06/28/2006 |
| K053493 | EVENFLO COMPANY, INC. | BERRY FRUITY TEETHER | 02/22/2006 |
| K052531 | FU HONG INDUSTRIES LTD. | FU HONG INDUSTRIES LIMITED SOOTHER TEETHER | 12/14/2005 |
| K093370 | FU HONG INDUSTRIES LTD. | FU HONG INDUSTRIES LIMITED SOOTHER TEETHER | 01/21/2010 |
| K043033 | GLOBAL TREASURE INDUSTRIES LTD. | GLOBAL TREASURES FLUID FILLED TEETHER | 03/22/2005 |
| K082824 | KIDS II | FLUID FILLED TEETHER | 05/27/2009 |
| K092025 | KIDS II | FLUID FILLED TEETHER - GEL | 01/27/2011 |
| K092494 | LUV N' CARE, LTD. | GEL FILLED GUM SOOTHER | 03/01/2010 |
| K093266 | MAM INTERNATIONAL AG | MAM COOLER | 07/27/2010 |
| K092781 | MAM INTERNATIONAL AG | MAM TWISTER | 06/23/2010 |
| K090167 | PHILIPS ELECTRONICS UK LIMITED | PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER, | 06/18/2009 |
| K092910 | QUALIMAN INDUSTRIAL CO., LTD | FLUID-FILLED TEETHER | 12/18/2009 |
| K963912 | REGU-TECH ASSOC., INC. | TYCO BABY SESAME STREET SOFT TEETHER | 11/06/1996 |
| K052105 | ROYAL INDUSTRIES (THAILAND) PUBLIC CO. LTD. | WATER FILLED TEETHER | 10/31/2005 |
| K031094 | ROYAL KING INFANT PRODUCTS CO. LTD. | FLUID FILLED TEETHERS | 12/08/2003 |
| K123855 | SOLID TOYS IND. LTD. | WATER-FILLED TEETHER | 05/24/2013 |
| K083512 | WILTEC INDUSTRIES LTD. | FLUID-FILLED TEETHER | 04/22/2009 |
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