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510(k) K072082

Device
GUMEASE DENTAL MOUTHPIECE
Applicant
Biomedevice , Ltd.
510(k) number
K072082
Product code
KKO
Decision
Substantially Equivalent (SESE)
Decision date
2007-11-05
Date received
2007-07-30
Regulation
872.5550
Classification name
Ring, Teething, Fluid-Filled
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
BRICE L YODER
Address
24931 Nellie Gail Rd. Laguna Hills CA US 92653 92653

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KKO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K123855WATER-FILLED TEETHERSolid Toys Ind. , Ltd.2013-05-24
K110615WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLEBebe Toys Manufactory , Ltd.2011-12-02
K092025FLUID FILLED TEETHER - GELKids II2011-01-27
K093266MAM COOLERMam International AG2010-07-27
K092781MAM TWISTERMam International AG2010-06-23
K092494GEL FILLED GUM SOOTHERLuv N' Care, Ltd.2010-03-01
K093370FU HONG INDUSTRIES LIMITED SOOTHER TEETHERFu Hong Industries , Ltd.2010-01-21
K092910FLUID-FILLED TEETHERQualiman Industrial Co., Ltd.2009-12-18
K091198LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHINGAllied Hill Enterprises, Ltd.2009-12-07
K090167PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER,Philips Electronics UK Limited2009-06-18
K082824FLUID FILLED TEETHERKids II2009-05-27
K083512FLUID-FILLED TEETHERWiltec Industries , Ltd.2009-04-22
K052513BABY SNOOPY WATER FILLED TEETHER, MODEL 95367Delta Enterprise Corporation2006-06-28
K053493BERRY FRUITY TEETHEREvenflo Company, Inc.2006-02-22
K052531FU HONG INDUSTRIES LIMITED SOOTHER TEETHERFu Hong Industries , Ltd.2005-12-14