LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING
FDA 510(k) clearance K091198 · decided 2009-12-07
Clearance details
- K-number
- K091198
- Device name
- LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING
- Applicant
- Allied Hill Enterprises, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-04-24
- Decision date
- 2009-12-07
- Days to decision
- 227 days
- Clearance type
- Traditional
- Product code
- KKO
- Device class
- 2
- Regulation number
- 872.5550
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Stoughton, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| WATER-FILLED TEETHER (K123855) | Solid Toys Ind. , Ltd. | 2013-05-24 |
| WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE (K110615) | Bebe Toys Manufactory , Ltd. | 2011-12-02 |
| FLUID FILLED TEETHER - GEL (K092025) | Kids II | 2011-01-27 |
| MAM COOLER (K093266) | Mam International AG | 2010-07-27 |
| MAM TWISTER (K092781) | Mam International AG | 2010-06-23 |
| GEL FILLED GUM SOOTHER (K092494) | Luv N' Care, Ltd. | 2010-03-01 |
| FU HONG INDUSTRIES LIMITED SOOTHER TEETHER (K093370) | Fu Hong Industries , Ltd. | 2010-01-21 |
| FLUID-FILLED TEETHER (K092910) | Qualiman Industrial Co., Ltd. | 2009-12-18 |
| PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER, (K090167) | Philips Electronics UK Limited | 2009-06-18 |
| FLUID FILLED TEETHER (K082824) | Kids II | 2009-05-27 |
| FLUID-FILLED TEETHER (K083512) | Wiltec Industries , Ltd. | 2009-04-22 |
| GUMEASE DENTAL MOUTHPIECE (K072082) | Biomedevice , Ltd. | 2007-11-05 |
Recalls involving this device
No recalls on record reference this clearance.