510(k) K091198
- Device
- LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING
- Applicant
- ALLIED HILL ENTERPRISES, LTD.
- 510(k) number
- K091198
- Product code
- KKO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-12-07
- Date received
- 2009-04-24
- Regulation
- 872.5550
- Classification name
- Ring, Teething, Fluid-filled
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL A WARE
- Address
- 34 Mcnamara St. Stoughton MA US 02072 02072
FDA Registration Numbers#
- 3025436467
- 3002857192
- 3043648115
- 3030726486
- 3008687634
- 3004957421
- 3013927145
- 3027519000
- 3007154355
- 3006891667
- 3016245319
- 3015277913
- 3014921777
- 3008711096
- 3006610790
- 3015485146
- 3027605322
- 3015177652
- 3006852457
- 3011118556
- 3038195017
- 3008138005
- 3007608864
- 3012134276
- 2381321
- 3009109684
- 3010435282
- 3004529379
- 3010626066
- 3003399181
- 3005630901
- 1217805
- 3014085509
- 3010332886
- 3010337881
- 3009124884
- 3005980667
- 3008191511
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KKO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K123855 | WATER-FILLED TEETHER | Solid Toys Ind. , Ltd. | 2013-05-24 |
| K110615 | WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE | Bebe Toys Manufactory , Ltd. | 2011-12-02 |
| K092025 | FLUID FILLED TEETHER - GEL | Kids II | 2011-01-27 |
| K093266 | MAM COOLER | Mam International AG | 2010-07-27 |
| K092781 | MAM TWISTER | Mam International AG | 2010-06-23 |
| K092494 | GEL FILLED GUM SOOTHER | Luv N' Care, Ltd. | 2010-03-01 |
| K093370 | FU HONG INDUSTRIES LIMITED SOOTHER TEETHER | Fu Hong Industries , Ltd. | 2010-01-21 |
| K092910 | FLUID-FILLED TEETHER | Qualiman Industrial Co., Ltd. | 2009-12-18 |
| K090167 | PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER, | Philips Electronics UK Limited | 2009-06-18 |
| K082824 | FLUID FILLED TEETHER | Kids II | 2009-05-27 |
| K083512 | FLUID-FILLED TEETHER | Wiltec Industries , Ltd. | 2009-04-22 |
| K072082 | GUMEASE DENTAL MOUTHPIECE | Biomedevice , Ltd. | 2007-11-05 |
| K052513 | BABY SNOOPY WATER FILLED TEETHER, MODEL 95367 | Delta Enterprise Corporation | 2006-06-28 |
| K053493 | BERRY FRUITY TEETHER | Evenflo Company, Inc. | 2006-02-22 |
| K052531 | FU HONG INDUSTRIES LIMITED SOOTHER TEETHER | Fu Hong Industries , Ltd. | 2005-12-14 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases